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HIRREM Developmental Study

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ClinicalTrials.gov Identifier: NCT02709369
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Sleep Initiation and Maintenance Disorders Anxiety Post-Traumatic Stress Disorder Hot Flashes Headache Traumatic Brain Injury Post Concussion Symptoms Device: HIRREM

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders
Study Start Date : August 2011
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : September 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Device: HIRREM
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.


Outcome Measures

Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: Data used for analysis of primary outcome is collected at the enrollment visit, and 1-2 weeks after the intervention is completed. ]
    Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis. Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds). For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed. The primary outcomes will be analysis for change from baseline to post-intervention, 1-2 weeks after intervention is completed.

  2. Baroreflex Sensitivity [ Time Frame: Data used for analysis of primary outcome is collected at the enrollment visit, and 1-2 weeks after the intervention is completed. ]
    Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard Baroreflex Sensitivity (BRS) software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis. Evaluation includes analysis for measures of spontaneous baroreflex sensitivity, in the frequency domain as high frequency (HF) alpha index (ms2), and in the time domain as Sequence BRS (Up, Down and All, ms/mmHg). The primary outcomes will be analysis for change from baseline to post-intervention, 1-2 weeks after intervention is completed.


Secondary Outcome Measures :
  1. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Data used for analysis of secondary outcomes is collected at the enrollment visit, 1-2 weeks after the intervention is completed, and 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 depression38. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Secondary outcomes will be analyzed for change from baseline to 1-2 weeks after completion of the intervention, and changes from baseline to 4-8 weeks after completion of the intervention.

  2. EQ-5D [ Time Frame: Data used for analysis of secondary outcomes is collected at the enrollment visit, 1-2 weeks after the intervention is completed, and 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. Secondary outcomes will be analyzed for changes from baseline to 1-2 weeks after completion of the intervention, and change from baseline to 4-8 weeks after completion of the intervention.

  3. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Data used for analysis of secondary outcomes is collected at the enrollment visit, 1-2 weeks after the intervention is completed, and 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. Secondary outcomes will be analyzed for changes from baseline to 1-2 weeks after completion of the intervention, and change from baseline to 4-8 weeks after completion of the intervention.

  4. Insomnia Severity Index (ISI) [ Time Frame: Data used for analysis of secondary outcomes is collected at the enrollment visit, 1-2 weeks after the intervention is completed, and 4-8 weeks after completion of the intervention. ]
    The severity of insomnia symptoms is measured using the ISI with each data collection visit. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. Secondary outcomes will be analyzed for changes from baseline to 1-2 weeks after completion of the intervention, and change from baseline to 4-8 weeks after completion of the intervention.

  5. PCL [ Time Frame: Data used for analysis of secondary outcomes is collected at the enrollment visit, 1-2 weeks after the intervention is completed, and 4-8 weeks after completion of the intervention. ]
    The PTSD Checklist (PCL) - Civilian (C) and Military (M) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian or military settings, respectively. The PCL measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. Secondary outcomes will be analyzed for changes from baseline to 1-2 weeks after completion of the intervention, and change from baseline to 4-8 weeks after completion of the intervention.

  6. Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [ Time Frame: Data used for analysis of secondary outcomes is collected at the enrollment visit, 1-2 weeks after the intervention is completed, and 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 (least to greatest symptom severity). Items are compared to levels before the head injury and are reported as a 24 hour recall. Secondary outcomes will be analyzed for changes from baseline to 1-2 weeks after completion of the intervention, and change from baseline to 4-8 weeks after completion of the intervention.

  7. Drop stick reaction time [ Time Frame: Data used for analysis of secondary outcomes is collected at the enrollment visit, 1-2 weeks after the intervention is completed, and 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. Secondary outcomes will be analyzed for changes from baseline to 1-2 weeks after completion of the intervention, and change from baseline to 4-8 weeks after completion of the intervention.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709369


Contacts
Contact: Study Coordinator 336-716-9447 WFHIRREM@wakehealth.edu

Locations
United States, North Carolina
Department of Neurology, Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Study Coordinator    336-716-9447    WFHIRREM@wakehealth.edu   
Principal Investigator: Charles H Tegeler, MD         
Sub-Investigator: Catherine L Tegeler, BS         
Sub-Investigator: Hossam A Shaltout, PhD         
Sub-Investigator: Sean L Simpson, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Charles H Tegeler, MD Wake Forest University Health Sciences
More Information

Publications:

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02709369     History of Changes
Other Study ID Numbers: IRB00017651
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared in publications and presentations. No plan to formally make individual participant data available for this exploratory study

Keywords provided by Wake Forest University Health Sciences:
HIRREM
Neuro-technology
Closed-loop
Acoustic stimulation
Allostatic
heart rate variability
baroreflex sensitivity
traumatic brain injury
sports concussion
PTSD
hot flashes
headache
insomnia

Additional relevant MeSH terms:
Disease
Brain Injuries
Brain Injuries, Traumatic
Headache
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Hot Flashes
Sleep Initiation and Maintenance Disorders
Post-Concussion Syndrome
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Trauma and Stressor Related Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating