HIRREM Developmental Study

Not Applicable

Completed

• Conditions: Anxiety; Headache; Traumatic Brain Injury; Sleep Initiation and Maintenance Disorders; Hot Flashes; Post-Traumatic Stress Disorder; Post Concussion Symptoms
• Interventions: Device: HIRREM

• Registration Number: NCT02709369
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-23
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-16
• Primary Completion: 2018-10-25
• Study Completion: 2018-10-25
• Status Verified: 2018-11
• Results First Submitted: 2019-11-08
• Results First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Results First Posted: 2019-12-24
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Male and female adults and children aged 11 years and older.
• Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form.
• Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached.
• Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others.

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Exclusion Criteria

• Subjects who fail to meet inclusion criteria.
• Subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission.
• Subjects physically unable to come to the study visits.
• Subjects with a known seizure disorder.
• Subjects with severe bilateral hearing impairment (HIRREM requires the use of headphones).
• Subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator.
• Subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active HIRREM	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.

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability Standard Deviation of NN Intervals (SDNN)	Baseline/Enrollment visit	Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Baroreflex Sensitivity Sequence Up	Up to two weeks after the intervention is completed	Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Baroreflex Sensitivity Sequence All	Up to 2 weeks after the intervention is completed	Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Baroreflex Sensitivity Sequence Down	Up to two weeks after the intervention is completed	Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Heart Rate Variability (SDNN)	Up to 2 weeks after the intervention is completed	Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Baroreflex Sensitivity High Frequency (HF) Alpha	Up to two weeks after the intervention is completed	Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	4-8 weeks after completion of the intervention	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.
Center for Epidemiologic Studies Depression Scale (CES-D)	4-8 weeks after completion of the intervention	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.
Drop Stick Reaction Testing	4-8 weeks after completion of the intervention	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.
Generalized Anxiety Disorder-7 (GAD-7)	4-8 weeks after completion of the intervention	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.
Posttraumatic Stress Disorder Checklist (PCL-C)	enrollment visit/baseline	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.
Euro Quality of Life--Five Dimension (EQ-5D)	4-8 weeks after completion of the intervention	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.
Posttraumatic Stress Disorder Checklist (PCL)	4-8 weeks after completion of the intervention	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.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)	4-8 weeks after completion of the intervention	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.

Trial Locations

Locations (1)

Department of Neurology, Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States