Trial Outcomes & Findings for Neurofeedback Impact on Veterans With mTBI (NCT NCT04195685)

NCT ID: NCT04195685

Last Updated: 2025-10-30

Results Overview

The HIT-6 is a 6-question tool designed to describe and communicate the way people feel and what they cannot do because of their headache. (6 questions, 3 min) Scores vary from 36 - 78. Higher score worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
• Results posted on: 2025-10-30

Participant Flow

Participant milestones

Measure	NFB Intervention The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
Overall Study STARTED	43	44
Overall Study Mid-treatment	39	39
Overall Study Post-treatment	37	38
Overall Study 2-month Follow up	36	38
Overall Study COMPLETED	36	38
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Measure	NFB Intervention The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
Overall Study Withdrawal by Subject	6	2
Overall Study Lost to Follow-up	1	4

Baseline Characteristics

Neurofeedback Impact on Veterans With mTBI

Baseline characteristics by cohort

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.	Total n=87 Participants Total of all reporting groups
Age, Continuous	45.8 years STANDARD_DEVIATION 7.7 • n=5 Participants	45.0 years STANDARD_DEVIATION 8.4 • n=7 Participants	45.4 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified ethnicity · African/Black	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified ethnicity · European/Caucasian	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified ethnicity · Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified ethnicity · Native American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified ethnicity · Hispanic	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified ethnicity · Hawaiian/Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified ethnicity · More than one ethnicity	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified ethnicity · Refused/Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Headache Impact Tool (HIT-6)	61.7 score on a scale STANDARD_DEVIATION 8.8 • n=5 Participants	62.8 score on a scale STANDARD_DEVIATION 5.6 • n=7 Participants	62.3 score on a scale STANDARD_DEVIATION 7.2 • n=5 Participants
NEUROQOLTBI Headache Tool	32.0 score on a scale STANDARD_DEVIATION 10.9 • n=5 Participants	31.7 score on a scale STANDARD_DEVIATION 8.5 • n=7 Participants	31.9 score on a scale STANDARD_DEVIATION 9.7 • n=5 Participants
Insomnia Severity Index (ISI)	19.4 score on a scale STANDARD_DEVIATION 4.6 • n=5 Participants	18.5 score on a scale STANDARD_DEVIATION 5.6 • n=7 Participants	19.0 score on a scale STANDARD_DEVIATION 5.1 • n=5 Participants
NEUROQOLTBI Sleep Disturbance	25.8 score on a scale STANDARD_DEVIATION 6.7 • n=5 Participants	26.0 score on a scale STANDARD_DEVIATION 6.0 • n=7 Participants	25.9 score on a scale STANDARD_DEVIATION 6.4 • n=5 Participants
QIK test accuracy index	232.9 score on a scale STANDARD_DEVIATION 39.0 • n=5 Participants	241.3 score on a scale STANDARD_DEVIATION 44.9 • n=7 Participants	237.1 score on a scale STANDARD_DEVIATION 42.0 • n=5 Participants
Quality of Life after Brain Injury (QOLIBRI)	46.3 score on a scale STANDARD_DEVIATION 17.3 • n=5 Participants	46.3 score on a scale STANDARD_DEVIATION 17.2 • n=7 Participants	46.3 score on a scale STANDARD_DEVIATION 17.3 • n=5 Participants
NEUROQOLTBI Satisfaction with roles and activities	23.1 score on a scale STANDARD_DEVIATION 7.4 • n=5 Participants	21.9 score on a scale STANDARD_DEVIATION 6.1 • n=7 Participants	22.5 score on a scale STANDARD_DEVIATION 6.8 • n=5 Participants
NEUROQOLTBI Ability to participate in social roles and activities	25.0 score on a scale STANDARD_DEVIATION 6.8 • n=5 Participants	24.4 score on a scale STANDARD_DEVIATION 5.7 • n=7 Participants	24.7 score on a scale STANDARD_DEVIATION 6.3 • n=5 Participants
General Symptom Scale (GSI)	166.6 score on a scale STANDARD_DEVIATION 83.7 • n=5 Participants	156.7 score on a scale STANDARD_DEVIATION 54.0 • n=7 Participants	161.7 score on a scale STANDARD_DEVIATION 68.9 • n=5 Participants
Depression, Anxiety and Stress Scale (DASS21)	24.2 score on a scale STANDARD_DEVIATION 15.3 • n=5 Participants	23.9 score on a scale STANDARD_DEVIATION 12.4 • n=7 Participants	24.1 score on a scale STANDARD_DEVIATION 13.9 • n=5 Participants
Post-Traumatic Stress Disorder Checklist (PCL-5)	40.7 score on a scale STANDARD_DEVIATION 20.4 • n=5 Participants	40.9 score on a scale STANDARD_DEVIATION 18.7 • n=7 Participants	40.8 score on a scale STANDARD_DEVIATION 19.6 • n=5 Participants
Patient Health Questionnaire-Depression (PHQ9)	14.3 score on a scale STANDARD_DEVIATION 6.6 • n=5 Participants	14.3 score on a scale STANDARD_DEVIATION 5.7 • n=7 Participants	14.3 score on a scale STANDARD_DEVIATION 6.2 • n=5 Participants
NEUROQOLTBI Positive affect and wellbeing	29.9 score on a scale STANDARD_DEVIATION 8.2 • n=5 Participants	29.8 score on a scale STANDARD_DEVIATION 5.8 • n=7 Participants	29.9 score on a scale STANDARD_DEVIATION 7.0 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

The HIT-6 is a 6-question tool designed to describe and communicate the way people feel and what they cannot do because of their headache. (6 questions, 3 min) Scores vary from 36 - 78. Higher score worse outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
Headache Impact Test (HIT-6) Mid-treatment	53.2 score on a scale Standard Deviation 9.8	61.4 score on a scale Standard Deviation 6.6
Headache Impact Test (HIT-6) Post-treatment	49.2 score on a scale Standard Deviation 10.4	60.9 score on a scale Standard Deviation 7.4
Headache Impact Test (HIT-6) 2-month follow-up	52.2 score on a scale Standard Deviation 11.5	62.6 score on a scale Standard Deviation 8.7

PRIMARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to the nature and response to headaches. (10 items, 5 minutes). Score range 10-50. Higher scores suggest worse outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
NEUROQOLTBI Headache Pain Short Form Mid-treatment	21.3 score on a scale Standard Deviation 11.3	28.5 score on a scale Standard Deviation 10.2
NEUROQOLTBI Headache Pain Short Form Post-treatment	18.9 score on a scale Standard Deviation 11.2	28.0 score on a scale Standard Deviation 11.6
NEUROQOLTBI Headache Pain Short Form 2-month follow-up	23.1 score on a scale Standard Deviation 13.0	32.4 score on a scale Standard Deviation 11.3

PRIMARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach

Seven question self-report instrument used to quantify perceived current insomnia. Targets past week's symptoms and daytime consequences consistent with DSM-IV criteria. (7 items, 5 min) Scores vary from 0 - 28. Higher score worse outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
Insomnia Severity Index (ISI) Mid-treatment	11.5 score on a scale Standard Deviation 7.1	17.2 score on a scale Standard Deviation 6.2
Insomnia Severity Index (ISI) Post-treatment	7.7 score on a scale Standard Deviation 7.3	17.1 score on a scale Standard Deviation 6.3
Insomnia Severity Index (ISI) 2-month follow-up	10.2 score on a scale Standard Deviation 7.9	17.0 score on a scale Standard Deviation 7.0

PRIMARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach

Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 8 questions related to the sleep experience and impact. (8 items, 5 minutes). Score range: 8-40. Higher scores suggest worse outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
NEUROQOLTBI Sleep Disturbance Short Form Mid-treatment	29.2 score on a scale Standard Deviation 8.1	22.0 score on a scale Standard Deviation 7.3
NEUROQOLTBI Sleep Disturbance Short Form Post-treatment	31.2 score on a scale Standard Deviation 9.9	22.3 score on a scale Standard Deviation 8.0
NEUROQOLTBI Sleep Disturbance Short Form 2-month follow-up	28.6 score on a scale Standard Deviation 9.9	22.7 score on a scale Standard Deviation 7.8

PRIMARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach

Computerized visual performance test to assess attention and impulse control, speed and consistency of response. Specifically intended for use by neurofeedback clinicians. (21 min). Higher scores indicate better performance. Score range: 165-420.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
QIKtest Continuous Performance Test - Accuracy Index Mid-treatment	252.0 score on a scale Standard Deviation 41.9	241.6 score on a scale Standard Deviation 50.1
QIKtest Continuous Performance Test - Accuracy Index Post-treatment	271.4 score on a scale Standard Deviation 60.8	247.3 score on a scale Standard Deviation 58.7
QIKtest Continuous Performance Test - Accuracy Index 2-month follow-up	254.4 score on a scale Standard Deviation 48.4	256.8 score on a scale Standard Deviation 56.8

PRIMARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

A 37-item instrument consisting of 6 scales measuring cognition, self, daily life and autonomy, social relationships, emotions, and physical problems. Designed to measure quality of life specific for TBI. (37 items, 15 min). Score range: 0-100. Higher score suggests better outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
Quality of Life After Brain Injury (QOLIBRI) Mid-treatment	127.4 score on a scale Standard Deviation 32.6	106.8 score on a scale Standard Deviation 27.4
Quality of Life After Brain Injury (QOLIBRI) Post-treatment	139.8 score on a scale Standard Deviation 36.3	107.6 score on a scale Standard Deviation 31.0
Quality of Life After Brain Injury (QOLIBRI) 2-month follow-up	133.8 score on a scale Standard Deviation 38.8	108.6 score on a scale Standard Deviation 30.3

PRIMARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of satisfaction with life roles and activities. (10 items, 5 min). Score range: 8-40. Higher score suggests better outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
NEUROQOLTBI Satisfaction With Social Roles and Activities Short Form Mid-treatment	33.5 score on a scale Standard Deviation 7.6	30.0 score on a scale Standard Deviation 6.8
NEUROQOLTBI Satisfaction With Social Roles and Activities Short Form Post-treatment	35.4 score on a scale Standard Deviation 8.7	31.2 score on a scale Standard Deviation 7.6
NEUROQOLTBI Satisfaction With Social Roles and Activities Short Form 2-month follow-up	34.8 score on a scale Standard Deviation 8.5	30.0 score on a scale Standard Deviation 7.5

PRIMARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of ability to do life roles and activities. (10 items, 5 min). Score range 8-40. Higher score suggests better outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
NEUROQOLTBI Ability to Participate in Social Roles and Activities Short Form Mid-treatment	29.1 score on a scale Standard Deviation 7.3	24.7 score on a scale Standard Deviation 5.8
NEUROQOLTBI Ability to Participate in Social Roles and Activities Short Form Post-treatment	31.0 score on a scale Standard Deviation 8.2	24.2 score on a scale Standard Deviation 6.7
NEUROQOLTBI Ability to Participate in Social Roles and Activities Short Form 2-month follow-up	29.7 score on a scale Standard Deviation 8.4	24.8 score on a scale Standard Deviation 6.6

PRIMARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of positive attitude and sense of well-being (9 items, 5 min). Score range: 9-45. Higher score better outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
NEUROQOLTBI Positive Affect and Well-being-short Form Mid-treatment	33.5 score on a scale Standard Deviation 7.3	30.2 score on a scale Standard Deviation 6.8
NEUROQOLTBI Positive Affect and Well-being-short Form Post-treatment	35.5 score on a scale Standard Deviation 8.2	31.0 score on a scale Standard Deviation 7.0
NEUROQOLTBI Positive Affect and Well-being-short Form 2-month follow-up	34.7 score on a scale Standard Deviation 8.5	30.1 score on a scale Standard Deviation 7.1

SECONDARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

DASS21 is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Can be used as a single assessment of psychological distress (21 items, 10 min). Score varies from 0 - 63. Higher score suggests worse outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
Depression, Anxiety and Stress Scale 21 (DASS21) Mid-treatment	12.0 score on a scale Standard Deviation 11.6	20.3 score on a scale Standard Deviation 12.4
Depression, Anxiety and Stress Scale 21 (DASS21) Post-treatment	10.2 score on a scale Standard Deviation 12.7	19.9 score on a scale Standard Deviation 13.4
Depression, Anxiety and Stress Scale 21 (DASS21) 2-month follow-up	13.3 score on a scale Standard Deviation 13.9	23.1 score on a scale Standard Deviation 13.6

SECONDARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

PHQ-9 is a nine-item depression self-report module from the full Patient Health Questionnaire. Scores range from 0-27. (9 items, 2-5 min) Score varies from 0-27. Higher score suggests worse outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
Patient Health Questionnaire-9 (PHQ-9) Mid-treatment	8.2 score on a scale Standard Deviation 6.8	12.2 score on a scale Standard Deviation 6.2
Patient Health Questionnaire-9 (PHQ-9) Post-treatment	5.7 score on a scale Standard Deviation 7.2	12.0 score on a scale Standard Deviation 6.7
Patient Health Questionnaire-9 (PHQ-9) 2-month follow-up	7.4 score on a scale Standard Deviation 7.5	13.1 score on a scale Standard Deviation 7.0

SECONDARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

The PCL-5 is a 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. (20 items, 5-10 min) Score varies from 0-80. Higher score suggests worse outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
Posttraumatic Stress Disorder Checklist (PCL-5) Mid-treatment	25.4 score on a scale Standard Deviation 19.3	35.7 score on a scale Standard Deviation 17.5
Posttraumatic Stress Disorder Checklist (PCL-5) Post-treatment	19.3 score on a scale Standard Deviation 20.2	33.7 score on a scale Standard Deviation 19.1
Posttraumatic Stress Disorder Checklist (PCL-5) 2-follow follow-up	23.0 score on a scale Standard Deviation 21.0	37.1 score on a scale Standard Deviation 20.3

SECONDARY outcome

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Population: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

Self-report instrument of symptoms in 7 categories including sleep, attention and learning, sensory, behavioral, emotional, physical, and pain (less than 10 min). Score varies from 0-464. Higher score suggests worse outcome.

Outcome measures

Measure	NFB Intervention n=43 Participants The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference.	Control Group n=44 Participants Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
General Symptom Inventory (GSI) Mid-treatment	108.7 score on a scale Standard Deviation 75.9	151.7 score on a scale Standard Deviation 61.0
General Symptom Inventory (GSI) Post-treatment	81.3 score on a scale Standard Deviation 90.2	139.4 score on a scale Standard Deviation 73.4
General Symptom Inventory (GSI) 2-month follow-up	103.1 score on a scale Standard Deviation 97.9	150.4 score on a scale Standard Deviation 72.9

Adverse Events

NFB Intervention

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Control Group

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	NFB Intervention n=43 participants at risk The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System, which enables training frequencies in the infra-low frequency range will be used. This will enable the individualized training to the person's brain training preference.	Control Group n=44 participants at risk Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies. Upon completion control group activities, participants had the option to receive the neurofeedback intervention. They then followed the NFB intervention protocol.
Psychiatric disorders Inpatient Hospitalization	2.3% 1/43 • Number of events 1 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	2.3% 1/44 • Number of events 1 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.

Other adverse events

Measure	NFB Intervention n=43 participants at risk The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System, which enables training frequencies in the infra-low frequency range will be used. This will enable the individualized training to the person's brain training preference.	Control Group n=44 participants at risk Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies. Upon completion control group activities, participants had the option to receive the neurofeedback intervention. They then followed the NFB intervention protocol.
Psychiatric disorders Psychological	4.7% 2/43 • Number of events 2 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	2.3% 1/44 • Number of events 1 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.
Infections and infestations Medical	2.3% 1/43 • Number of events 1 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	4.5% 2/44 • Number of events 2 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.
Surgical and medical procedures Medical	0.00% 0/43 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	2.3% 1/44 • Number of events 1 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.
Respiratory, thoracic and mediastinal disorders Medical	0.00% 0/43 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	13.6% 6/44 • Number of events 6 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.
Nervous system disorders Medical	0.00% 0/43 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	2.3% 1/44 • Number of events 1 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.
Cardiac disorders Medical	0.00% 0/43 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	2.3% 1/44 • Number of events 1 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.
General disorders Medical	0.00% 0/43 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	2.3% 1/44 • Number of events 3 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.
Vascular disorders Medical	0.00% 0/43 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	2.3% 1/44 • Number of events 1 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.
Eye disorders Medical	0.00% 0/43 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.	2.3% 1/44 • Number of events 1 • Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.

Additional Information

Dr. Judy Carlson

VA Pacific Islands Healthcare System

Phone: 808-433-6677

Email: judy.carlson@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place