The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neuro-technology to facilitate recipient-unique relaxation, auto-calibration, and self-optimization of cortical neural oscillations by reflecting auditory tones in near real time. After an initial HIRREM assessment, evaluating patterns of brain electrical rhythms, subjects get a series of 90-120 minute HIRREM sessions, including 5 to 9 individualized protocols. A protocol is a combination of sensor montage and specific software design, during which dominant brain frequencies, recorded at high spectral resolutions, are translated to audible tones, and reflected back via earphones with as little as 8 milliseconds delay. Protocols are received sitting or reclining in a chair, some with eyes open, others eyes closed.
Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Time frame: Baseline/Enrollment visit
Heart Rate Variability (SDNN)
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Time frame: Up to 2 weeks after the intervention is completed
Baroreflex Sensitivity High Frequency (HF) Alpha
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time frame: Baseline/Enrollment visit
Baroreflex Sensitivity High Frequency (HF) Alpha
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time frame: Up to two weeks after the intervention is completed
Baroreflex Sensitivity Sequence Up
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time frame: Baseline/Enrollment visit
Baroreflex Sensitivity Sequence Up
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time frame: Up to two weeks after the intervention is completed
Baroreflex Sensitivity Sequence Down
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time frame: Baseline/Enrollment visit
Baroreflex Sensitivity Sequence Down
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time frame: Up to two weeks after the intervention is completed
Baroreflex Sensitivity Sequence All
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time frame: Baseline/Enrollment visit
Baroreflex Sensitivity Sequence All
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time frame: Up to 2 weeks after the intervention is completed
Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Time frame: enrollment visit/baseline
Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Time frame: 1-2 weeks after intervention is completed
Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Time frame: 4-8 weeks after completion of the intervention
Euro Quality of Life--Five Dimension (EQ-5D)
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.
Time frame: enrollment visit/baseline
Euro Quality of Life--Five Dimension (EQ-5D)
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.
Time frame: 1-2 weeks after the intervention is completed
Euro Quality of Life--Five Dimension (EQ-5D)
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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.
Time frame: 4-8 weeks after completion of the intervention
Generalized Anxiety Disorder-7 (GAD-7)
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.
Time frame: enrollment visit/baseline
Generalized Anxiety Disorder-7 (GAD-7)
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.
Time frame: 1-2 weeks after the intervention is completed
Generalized Anxiety Disorder-7 (GAD-7)
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.
Time frame: 4-8 weeks after completion of the intervention
Insomnia Severity Index (ISI)
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.
Time frame: enrollment visit/baseline
Insomnia Severity Index (ISI)
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.
Time frame: 1-2 weeks after the intervention is completed
Insomnia Severity Index (ISI)
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.
Time frame: 4-8 weeks after completion of the intervention
Posttraumatic Stress Disorder Checklist (PCL-C)
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.
Time frame: enrollment visit/baseline
Posttraumatic Stress Disorder Checklist (PCL)
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.
Time frame: 1-2 weeks after the intervention is completed
Posttraumatic Stress Disorder Checklist (PCL)
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.
Time frame: 4-8 weeks after completion of the intervention
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
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.
Time frame: enrollment visit/baseline
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
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.
Time frame: 1-2 weeks after the intervention is completed
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
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.
Time frame: 4-8 weeks after completion of the intervention
Drop Stick Reaction Testing
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.
Time frame: enrollment visit/baseline
Drop Stick Reaction Testing
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.
Time frame: 1-2 weeks after the intervention is completed
Drop Stick Reaction Testing
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.
Time frame: 4-8 weeks after completion of the intervention