Trial Outcomes & Findings for HIRREM Developmental Study (NCT NCT02709369)

NCT ID: NCT02709369

Last Updated: 2019-12-24

Results Overview

Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: Baseline/Enrollment visit
• Results posted on: 2019-12-24

Participant Flow

Participant milestones

Measure	Active HIRREM This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Overall Study STARTED	300
Overall Study COMPLETED	273
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Active HIRREM This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Overall Study Lost to Follow-up	15
Overall Study Withdrawal by Subject	10
Overall Study Did not received intervention	2

Baseline Characteristics

HIRREM Developmental Study

Baseline characteristics by cohort

Measure	Active HIRREM n=300 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Age, Categorical <=18 years	30 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	228 Participants n=5 Participants
Age, Categorical >=65 years	42 Participants n=5 Participants
Sex: Female, Male Female	166 Participants n=5 Participants
Sex: Female, Male Male	134 Participants n=5 Participants
Race/Ethnicity, Customized African American	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants
Race/Ethnicity, Customized White	276 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	300 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline/Enrollment visit

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

Outcome measures

Measure	Active HIRREM n=227 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Heart Rate Variability Standard Deviation of NN Intervals (SDNN)	44.41 milliseconds Standard Deviation 22.94

PRIMARY outcome

Timeframe: Up to 2 weeks after the intervention is completed

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

Outcome measures

Measure	Active HIRREM n=227 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Heart Rate Variability (SDNN)	54.82 milliseconds Standard Deviation 30.63

PRIMARY outcome

Timeframe: Baseline/Enrollment visit

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Measure	Active HIRREM n=227 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Baroreflex Sensitivity High Frequency (HF) Alpha	18.81 ms^2 Standard Deviation 14.45

PRIMARY outcome

Timeframe: Up to two weeks after the intervention is completed

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Measure	Active HIRREM n=227 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Baroreflex Sensitivity High Frequency (HF) Alpha	26.68 ms^2 Standard Deviation 20.69

PRIMARY outcome

Timeframe: Baseline/Enrollment visit

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Measure	Active HIRREM n=226 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Baroreflex Sensitivity Sequence Up	15.39 ms/mmHg Standard Deviation 13.88

PRIMARY outcome

Timeframe: Up to two weeks after the intervention is completed

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Measure	Active HIRREM n=226 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Baroreflex Sensitivity Sequence Up	14.15 ms/mmHg Standard Deviation 11.56

PRIMARY outcome

Timeframe: Baseline/Enrollment visit

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Measure	Active HIRREM n=227 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Baroreflex Sensitivity Sequence Down	14.15 ms/mmHg Standard Deviation 11.56

PRIMARY outcome

Timeframe: Up to two weeks after the intervention is completed

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Measure	Active HIRREM n=227 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Baroreflex Sensitivity Sequence Down	20.73 ms/mmHg Standard Deviation 16.76

PRIMARY outcome

Timeframe: Baseline/Enrollment visit

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Measure	Active HIRREM n=227 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Baroreflex Sensitivity Sequence All	14.63 ms/mmHg Standard Deviation 11.80

PRIMARY outcome

Timeframe: Up to 2 weeks after the intervention is completed

Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Measure	Active HIRREM n=227 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Baroreflex Sensitivity Sequence All	20.74 ms/mmHg Standard Deviation 16.30

SECONDARY outcome

Timeframe: enrollment visit/baseline

Population: CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.

The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.

Outcome measures

Measure	Active HIRREM n=233 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Center for Epidemiologic Studies Depression Scale (CES-D)	18.12 score on a scale Standard Deviation 12.16

SECONDARY outcome

Timeframe: 1-2 weeks after intervention is completed

Population: CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.

The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.

Outcome measures

Measure	Active HIRREM n=233 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Center for Epidemiologic Studies Depression Scale (CES-D)	10.00 score on a scale Standard Deviation 8.96

SECONDARY outcome

Timeframe: 4-8 weeks after completion of the intervention

Population: CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.

The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.

Outcome measures

Measure	Active HIRREM n=115 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Center for Epidemiologic Studies Depression Scale (CES-D)	8.91 score on a scale Standard Deviation 8.28

SECONDARY outcome

Timeframe: enrollment visit/baseline

Population: EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data.

The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.

Outcome measures

Measure	Active HIRREM n=202 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Euro Quality of Life--Five Dimension (EQ-5D)	69.55 score on a scale Standard Deviation 19.69

SECONDARY outcome

Timeframe: 1-2 weeks after the intervention is completed

Population: EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data.

The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.

Outcome measures

Measure	Active HIRREM n=202 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Euro Quality of Life--Five Dimension (EQ-5D)	79.12 score on a scale Standard Deviation 16.42

SECONDARY outcome

Timeframe: 4-8 weeks after completion of the intervention

Population: EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.

The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.

Outcome measures

Measure	Active HIRREM n=151 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Euro Quality of Life--Five Dimension (EQ-5D)	78.36 score on a scale Standard Deviation 17.84

SECONDARY outcome

Timeframe: enrollment visit/baseline

Population: GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.

The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.

Outcome measures

Measure	Active HIRREM n=167 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Generalized Anxiety Disorder-7 (GAD-7)	8.31 score on a scale Standard Deviation 6.01

SECONDARY outcome

Timeframe: 1-2 weeks after the intervention is completed

Population: GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.

The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.

Outcome measures

Measure	Active HIRREM n=167 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Generalized Anxiety Disorder-7 (GAD-7)	4.35 score on a scale Standard Deviation 4.19

SECONDARY outcome

Timeframe: 4-8 weeks after completion of the intervention

Population: GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.

The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.

Outcome measures

Measure	Active HIRREM n=133 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Generalized Anxiety Disorder-7 (GAD-7)	3.66 score on a scale Standard Deviation 3.49

SECONDARY outcome

Timeframe: enrollment visit/baseline

Population: Entries were excluded if there was incomplete or missing data.

The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.

Outcome measures

Measure	Active HIRREM n=272 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Insomnia Severity Index (ISI)	13.47 score on a scale Standard Deviation 7.17

SECONDARY outcome

Timeframe: 1-2 weeks after the intervention is completed

Population: Entries were excluded if there was incomplete or missing data.

The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.

Outcome measures

Measure	Active HIRREM n=270 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Insomnia Severity Index (ISI)	7.09 score on a scale Standard Deviation 5.90

SECONDARY outcome

Timeframe: 4-8 weeks after completion of the intervention

Population: Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.

The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.

Outcome measures

Measure	Active HIRREM n=160 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Insomnia Severity Index (ISI)	6.22 score on a scale Standard Deviation 5.43

SECONDARY outcome

Timeframe: enrollment visit/baseline

Population: Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form.

The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.

Outcome measures

Measure	Active HIRREM n=179 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Posttraumatic Stress Disorder Checklist (PCL-C)	38.75 score on a scale Standard Deviation 15.43

SECONDARY outcome

Timeframe: 1-2 weeks after the intervention is completed

Population: Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form.

The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.

Outcome measures

Measure	Active HIRREM n=179 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Posttraumatic Stress Disorder Checklist (PCL)	28.50 score on a scale Standard Deviation 11.37

SECONDARY outcome

Timeframe: 4-8 weeks after completion of the intervention

Population: Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.

The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.

Outcome measures

Measure	Active HIRREM n=91 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Posttraumatic Stress Disorder Checklist (PCL)	26.13 score on a scale Standard Deviation 9.58

SECONDARY outcome

Timeframe: enrollment visit/baseline

Population: Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form.

The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.

Outcome measures

Measure	Active HIRREM n=48 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)	29.60 score on a scale Standard Deviation 12.82

SECONDARY outcome

Timeframe: 1-2 weeks after the intervention is completed

Population: Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form.

The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity.

Outcome measures

Measure	Active HIRREM n=48 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)	15.79 score on a scale Standard Deviation 13.96

SECONDARY outcome

Timeframe: 4-8 weeks after completion of the intervention

Population: Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.

The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.

Outcome measures

Measure	Active HIRREM n=35 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)	16.89 score on a scale Standard Deviation 14.74

SECONDARY outcome

Timeframe: enrollment visit/baseline

Population: Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.

Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.

Outcome measures

Measure	Active HIRREM n=213 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Drop Stick Reaction Testing	27.20 cm Standard Deviation 8.25

SECONDARY outcome

Timeframe: 1-2 weeks after the intervention is completed

Population: Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.

Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.

Outcome measures

Measure	Active HIRREM n=213 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Drop Stick Reaction Testing	23.40 cm Standard Deviation 6.78

SECONDARY outcome

Timeframe: 4-8 weeks after completion of the intervention

Population: Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.

Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.

Outcome measures

Measure	Active HIRREM n=90 Participants This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Drop Stick Reaction Testing	22.58 cm Standard Deviation 5.78

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-8 weeks after completion of the intervention

Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-8 weeks after completion of the intervention

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-8 weeks after completion of the intervention

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-8 weeks after completion of the intervention

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-8 weeks after completion of the intervention

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Outcome measures

Outcome data not reported

Adverse Events

Active HIRREM

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. Charles H. Tegeler

Wake Forest School of Medicine

Phone: +1 (336) 716-7651

Email: ctegeler@wakehealth.edu

Results disclosure agreements

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