Trial Outcomes & Findings for Transcranial Electrical Stimulation for mTBI (NCT NCT03244475)

Results Overview

We will develop a voxel-wise whole brain MEG source imaging approach for detecting abnormal Magnetoencephalography (MEG) slow-waves (1-4 Hz) in mTBI Veterans. The unit of the abnormal MEG source activity was measured in pico Ampere-meter (or pA-m which is 10\^(-12) A-m). Natural logarithm transformation (i.e., e-based) was used. So, the unit of the MEG source imaging was log(pA-m). The range of the voxel-wise MEG source activity scale is 0-10. High amplitude of the MEG source activity suggests more serious injury. In the present study, we measured the Difference score in MEG exam pre- vs post the transcranial electrical stimulation (TES) treatment. Our primary measure is the reduction of the abnormal MEG source activity for slow waves (1-4 Hz), defined as the MEG activity at the pre-TES exam minus that at the post-TES exam. So, the higher this difference score is, the better outcomes due to the TES treatment in reducing the abnormal MEG signal.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Baseline through end of treatment, an average of 6 weeks

Results posted on

2024-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Transcranial Electrical Stimulation (TES) mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Overall Study STARTED	30	17	19
Overall Study COMPLETED	18	4	19
Overall Study NOT COMPLETED	12	13	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Electrical Stimulation for mTBI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial Electrical Stimulation (TES) n=30 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=17 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	66 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	38.17857143 years STANDARD_DEVIATION 10.06072126 • n=5 Participants	38.375 years STANDARD_DEVIATION 6.945097192 • n=7 Participants	39.68421053 years STANDARD_DEVIATION 7.643728985 • n=5 Participants	38.68253968 years STANDARD_DEVIATION 8.677329332 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	62 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	52 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	30 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	66 Participants n=4 Participants
Handedness	28 Participants Right Handed n=5 Participants	17 Participants Right Handed n=7 Participants	19 Participants Right Handed n=5 Participants	64 Participants Right Handed n=4 Participants
Education Level	15.03703704 years STANDARD_DEVIATION 3.024363802 • n=5 Participants	14.8125 years STANDARD_DEVIATION 1.911110606 • n=7 Participants	15.94736842 years STANDARD_DEVIATION 2.139200151 • n=5 Participants	15.25806452 years STANDARD_DEVIATION 2.558574981 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline through end of treatment, an average of 6 weeks

Population: \# of TES participants analyzed differs from the # of TES participants enrolled. mTBI veterans who were blindly placed in the TES Sham group had the option of completing TES sessions at the end of their original sessions. Therefore, some TES Sham participants opted to complete TES sessions, with questionnaires and pre-post MEG imaging.

We will develop a voxel-wise whole brain MEG source imaging approach for detecting abnormal Magnetoencephalography (MEG) slow-waves (1-4 Hz) in mTBI Veterans. The unit of the abnormal MEG source activity was measured in pico Ampere-meter (or pA-m which is 10\^(-12) A-m). Natural logarithm transformation (i.e., e-based) was used. So, the unit of the MEG source imaging was log(pA-m). The range of the voxel-wise MEG source activity scale is 0-10. High amplitude of the MEG source activity suggests more serious injury. In the present study, we measured the Difference score in MEG exam pre- vs post the transcranial electrical stimulation (TES) treatment. Our primary measure is the reduction of the abnormal MEG source activity for slow waves (1-4 Hz), defined as the MEG activity at the pre-TES exam minus that at the post-TES exam. So, the higher this difference score is, the better outcomes due to the TES treatment in reducing the abnormal MEG signal.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=38 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=17 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Change in Abnormal Magnetoencephalography (MEG) Slow-Waves (1-4 Hz) Activity	1.8 units on a scale Standard Deviation 1.2	0.2 units on a scale Standard Deviation 1.4	0 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Baseline through end of treatment, an average of 6 weeks

The Rivermead Post Concussion Symptom Questionnaire (RPQ) total score was used to assess change in post-concussion symptoms due to TES. Our focus in this analysis was the difference score in RPQ total score pre- vs post-treatment measures. The questionnaire has 16 items and uses scale of 0 - 4, with 0 as "not experienced at all" and 4 as "a severe problem." Value range: 0 - 64, where the higher scores mean a worse outcome. For this measure, we focused on the difference score: total score from prior to treatment minus total score from end of treatment. Therefore, the higher the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=25 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=15 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Rivermead Post Concussion Symptom Questionnaire	11.1 units on a scale Standard Deviation 9.7	10.9 units on a scale Standard Deviation 11.2	0 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Baseline through end of treatment, an average of 6 weeks

The Neurobehavioral Symptoms Inventory (NSI) total score was used to assess the changes of post-concussion symptoms due to TES. Our focus in this analysis was the difference score in NSI total score pre- vs post-treatment measures. The NSI has 22 items and uses a response scale of 0 - 4, with 0 as "none" and 4 as "very severe." Value range: 0 - 88, where the higher scores mean a worse outcome/more severe post-concussive symptoms. For this measure, we focused on the difference score: total score from prior to treatment minus total score from end of treatment. Therefore, the higher the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=25 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=15 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Neurobehavioral Symptoms Inventory	12.3 units on a scale Standard Deviation 13.0	12.7 units on a scale Standard Deviation 10.7	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline through end of treatment, an average of 6 weeks

Population: Some participants did not complete the MGPQ and/or did not complete all study visits, therefore, no statistical analysis was completed on this measure.

The McGill Pain Questionnaire (MGPQ) will evaluate the level of current pain, pain changes over time, and strength of pain, since pain is frequently co-morbid with mTBI. Category scores range from 1-2 through 1-6. Minimum score = 0. Maximum score = 78. The higher the pain score, the greater the pain. For this measure, we focused on the difference score: total score from prior to treatment minus total score from end of treatment. Therefore, the higher the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=19 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=10 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=10 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
The McGill Pain Questionnaire (MGPQ)	14.8 units on a scale Standard Deviation 16.9	-5.1 units on a scale Standard Deviation 18.1	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 6 weeks

The CAPS-5 is a standard semi-structured interview used to assess PTSD diagnosis and severity. The primary traumatic event is elicited and will be used as the basis of assessing PTSD symptoms. The total symptom severity score is calculated by summing severity scores assessed in this 30-item questionnaire. PTSD diagnostic status will be assessed using the past month version of the CAPS-5A, in which total severity score of 33 or higher indicates full threshold PTSD. The past week version of the CAPS-5 will be given prior to treatment and at follow-up. Severity scores range on a response scale of 0-5, 0=absent, 5=extreme/incapacitating. CAPS-55 summary scores range from 0 to 80, with the higher scores indicating greater severity of PTSD symptoms. For this measure, we focused on the difference score: total score from prior to treatment minus total score from end of treatment. Therefore, the higher the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=22 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=11 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=16 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Clinician-Administered PTSD Scale (CAPS-5)	6.5 units on a scale Standard Deviation 13.4	4.2 units on a scale Standard Deviation 9.6	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 6 weeks

PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 uses a response scale of 0 - 4. 0 = "Not at all" to 4 = "Extremely." The total score can range from 0 - 80, with the higher the score corresponding to a higher level of distress to the very stressful experience. The difference between scores post-treatment and pre-treatment will analyzed in addition to the CAPS-5 (1 week version) outcomes. DSM-5 symptom cluster severity scores can be obtained by summing the scores for the items within a given cluster, i.e., cluster B (items 1-5), cluster C (items 6-7), cluster D (items 8-14), and cluster E (items 15-20); these subscale scores may be used in secondary analysis.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=26 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=15 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Post-Concussion Check List (PCL-5)	14.9 units on a scale Standard Deviation 15.9	12.1 units on a scale Standard Deviation 24.3	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 6 weeks

We will use T-scores from verbal learning and retrospective memory (California Verbal Learning Test-2nd Edition). Alternate CVLT forms were used during the post-treatment session. T-score ranges from 5 to 95, where the higher the T-score, the better the outcome. The T-score indicates the number of standard deviations away from the mean, where 50 is the mean with a standard deviation of 10, and is age- and gender-corrected. Analysis was based on the difference score between pre-treatment and post-treatment Free Recall Total Correct T-score. The lower the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=27 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=15 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
California Verbal Learning Test-2nd Edition - Free Recall Total Correct T-score	-6.7 CVLT Free Recall Total Correct t-score Standard Deviation 9.8	-2.8 CVLT Free Recall Total Correct t-score Standard Deviation 7.4	0 CVLT Free Recall Total Correct t-score Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 6 weeks

We will use the sum of scaled scores from the WAIS-IV Symbol Search and Coding subtests to attain the Processing Speed Index. PSI ranged from 50 - 150, where the higher the score, the better the outcome. Analysis was based on the difference score between pre-treatment Processing Speed Index and post-treatment Processing Speed Index. The lower the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=27 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=15 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Wechsler Adult Intelligence Scale-4th Edition (WAIS-IV) Processing Speed Index	-5.06 units on a scale Standard Deviation 10.53	-11.48 units on a scale Standard Deviation 11.21	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 6 weeks

Throughout the study, we used DKEFS Verbal Fluency, Trail-Making, and Color-Word Interference subtests to assess executive functioning. Analysis was based on the DKEFS Trailmaking Number/Letter Switching scaled score. Scaled scores range from 1-19, where the higher the scaled score, the better the outcome. Analysis was based on the difference score between pre-treatment scaled score and the post-treatment scaled score. The lower the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=27 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=15 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Delis-Kaplan Executive Function System (DKEFS) - Trail Number/Letter Switching Scaled	-0.77 units on a scale Standard Deviation 1.13	-2.08 units on a scale Standard Deviation 2.03	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 6 weeks

The Connors Continuous Performance Task II (CPT-II) was included as a measure of attention and impulsivity. In this measure, converted T-scores represent the score of the individual relative to the population, who are of the same gender and same age group. A T-score of 50 represents the average for the comparison group. T-score ranges from under 40 (very good performance) to 65+ (markedly atypical). The higher the scores, the worse the performance. This analysis focused on the difference score between the Inattention Omissions T-score pre- and post-treatment. The higher the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=27 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=15 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Connors Continuous Performance Task II (CPT-II) - Inattention Omissions T-Score	5.71 Inattention Omissions T-score Standard Deviation 8.04	-0.89 Inattention Omissions T-score Standard Deviation 10.02	0 Inattention Omissions T-score Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 6 weeks

Impulsivity was also measured by Barratt Impulsivity Scale, a self-report questionnaire. This scale contains 30 items, with total scores that range from 30 - 120. The higher the score, the worse the outcome. Analysis was based on the difference score between pre- and post-treatment. The higher the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=24 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=15 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=19 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Barratt Impulsivity Scale	7.6 units on a scale Standard Deviation 8.1	2.4 units on a scale Standard Deviation 10.8	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline through end of treatment, an average of 6 weeks

Population: Some participants did not complete the FrSBe and/or did not complete all study visits, but analysis was completed on those who finished the FRsBe.

Since frontal lobe areas are more prone to damage, the Frontal Systems Behavior Scale (FrSBe) will measure behavioral dysfunction associated with frontal subcortical impairment. FrSBe is a 46-item rating scale with three subscales: Apathy (14 items), Disinhibition (15 items), and Executive Function (17 items). Items are rated in a 5-point scale, where higher scores mean a worse outcome. The raw scores of these subscales were converted to T-scores, with range of 9 - \>/= 140, where T-scores greater than 65 are considered clinically significant. For this measure, we focused on the difference score of the total T-score prior to treatment minus total score from end of treatment. Therefore, the higher the difference score, the more positive change was observed.

Outcome measures

Outcome measures
Measure	Transcranial Electrical Stimulation (TES) n=24 Participants mTBI Veterans blindly assigned to a 6-week IASIS neurofeedback treatment with two sessions per week. If participants in the mTBI group may have remaining PCS, additional Nexalin treatment will be offered. Nexalin TES will be administered once per day, Monday through Friday. Participants will receive 10-20 treatments, 3-4 times a week for 4 weeks, or up to 5 times a week for 4 weeks.	TES Sham Treatment n=15 Participants mTBI Veterans blindly assigned to a sham treatment for 6 weeks with two IASIS sessions per week or 10-20 Nexalin treatments, 3-4 times a week for 4 weeks or up to 5 times a week for 4 weeks.	Control n=15 Participants Veterans who are age-, gender-, education-, combat exposure-, and socioeconomically-matched. They will not undergo a treatment.
Frontal Systems Behavior Scale	9.1 T-score Standard Deviation 13.1	3.2 T-score Standard Deviation 17.2	0 T-score Standard Deviation 0

Adverse Events

Transcranial Electrical Stimulation (TES)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TES Sham Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mingxiong Huang

VA San Diego Health System

Phone: 858-534-1254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place