Clinical trial NCT02709369: HIRREM Developmental Study
Official title: Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Anxiety
Post-Traumatic Stress Disorder
Hot Flashes
Headache
Traumatic Brain Injury
Post Concussion Symptoms
Keywords: HIRREM
Neuro-technology
Closed-loop
Acoustic stimulation
Allostatic
heart rate variability
baroreflex sensitivity
traumatic brain injury
sports concussion
PTSD
hot flashes
headache
insomnia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 300
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
timeFrame: Baseline/Enrollment visit
measure: Heart Rate Variability (SDNN)
timeFrame: Up to 2 weeks after the intervention is completed
measure: Baroreflex Sensitivity High Frequency (HF) Alpha
timeFrame: Baseline/Enrollment visit
measure: Baroreflex Sensitivity High Frequency (HF) Alpha
timeFrame: Up to two weeks after the intervention is completed
measure: Baroreflex Sensitivity Sequence Up
timeFrame: Baseline/Enrollment visit
measure: Baroreflex Sensitivity Sequence Up
timeFrame: Up to two weeks after the intervention is completed
measure: Baroreflex Sensitivity Sequence Down
timeFrame: Baseline/Enrollment visit
measure: Baroreflex Sensitivity Sequence Down
timeFrame: Up to two weeks after the intervention is completed
measure: Baroreflex Sensitivity Sequence All
timeFrame: Baseline/Enrollment visit
measure: Baroreflex Sensitivity Sequence All
timeFrame: Up to 2 weeks after the intervention is completed
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: enrollment visit/baseline
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 1-2 weeks after intervention is completed
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 4-8 weeks after completion of the intervention
measure: Euro Quality of Life--Five Dimension (EQ-5D)
timeFrame: enrollment visit/baseline
measure: Euro Quality of Life--Five Dimension (EQ-5D)
timeFrame: 1-2 weeks after the intervention is completed
measure: Euro Quality of Life--Five Dimension (EQ-5D)
timeFrame: 4-8 weeks after completion of the intervention
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: enrollment visit/baseline
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 1-2 weeks after the intervention is completed
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 4-8 weeks after completion of the intervention
measure: Insomnia Severity Index (ISI)
timeFrame: enrollment visit/baseline
measure: Insomnia Severity Index (ISI)
timeFrame: 1-2 weeks after the intervention is completed
measure: Insomnia Severity Index (ISI)
timeFrame: 4-8 weeks after completion of the intervention
measure: Posttraumatic Stress Disorder Checklist (PCL-C)
timeFrame: enrollment visit/baseline
measure: Posttraumatic Stress Disorder Checklist (PCL)
timeFrame: 1-2 weeks after the intervention is completed
measure: Posttraumatic Stress Disorder Checklist (PCL)
timeFrame: 4-8 weeks after completion of the intervention
measure: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
timeFrame: enrollment visit/baseline
measure: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
timeFrame: 1-2 weeks after the intervention is completed
measure: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
timeFrame: 4-8 weeks after completion of the intervention
measure: Drop Stick Reaction Testing
timeFrame: enrollment visit/baseline
measure: Drop Stick Reaction Testing
timeFrame: 1-2 weeks after the intervention is completed
measure: Drop Stick Reaction Testing
timeFrame: 4-8 weeks after completion of the intervention
Other outcomes:
measure: Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
timeFrame: 4-8 weeks after completion of the intervention
measure: Baroreflex Sensitivity High Frequency (HF) Alpha
timeFrame: 4-8 weeks after completion of the intervention
measure: Baroreflex Sensitivity Sequence Up
timeFrame: 4-8 weeks after completion of the intervention
measure: Baroreflex Sensitivity Sequence Down
timeFrame: 4-8 weeks after completion of the intervention
measure: Baroreflex Sensitivity Sequence All
timeFrame: 4-8 weeks after completion of the intervention
Locations:
city: Winston-Salem
country: United States
facility: Department of Neurology, Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles H Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.
citation: Tegeler CH, Kumar SR, Conklin D, Lee SW, Gerdes L, Turner DP, Tegeler CL, C Fidali B, Houle TT. Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia. Brain Behav. 2012 Nov;2(6):814-24. doi: 10.1002/brb3.101. Epub 2012 Oct 28.
citation: Tegeler CH, Lee SW, Shaltout HA. Significance of right anterior insula activity for mental health intervention. JAMA Psychiatry. 2014 Mar;71(3):336. doi: 10.1001/jamapsychiatry.2013.3507. No abstract available.
citation: Gerdes L, Tegeler CH, Lee SW. A groundwork for allostatic neuro-education. Front Psychol. 2015 Aug 17;6:1224. doi: 10.3389/fpsyg.2015.01224. eCollection 2015.
citation: Lee SW, Gerdes L, Tegeler CL, Shaltout HA, Tegeler CH. A bihemispheric autonomic model for traumatic stress effects on health and behavior. Front Psychol. 2014 Aug 1;5:843. doi: 10.3389/fpsyg.2014.00843. eCollection 2014.
citation: Tegeler CH, Tegeler CL, Cook JF, Lee SW, Pajewski NM. Reduction in menopause-related symptoms associated with use of a noninvasive neurotechnology for autocalibration of neural oscillations. Menopause. 2015 Jun;22(6):650-5. doi: 10.1097/GME.0000000000000422.
citation: Tegeler CH, Shaltout HA, Tegeler CL, Gerdes L, Lee SW. Rightward dominance in temporal high-frequency electrical asymmetry corresponds to higher resting heart rate and lower baroreflex sensitivity in a heterogeneous population. Brain Behav. 2015 Jun;5(6):e00343. doi: 10.1002/brb3.343. Epub 2015 May 1.
citation: Fortunato JE, Tegeler CL, Gerdes L, Lee SW, Pajewski NM, Franco ME, Cook JF, Shaltout HA, Tegeler CH. Use of an allostatic neurotechnology by adolescents with postural orthostatic tachycardia syndrome (POTS) is associated with improvements in heart rate variability and changes in temporal lobe electrical activity. Exp Brain Res. 2016 Mar;234(3):791-8. doi: 10.1007/s00221-015-4499-y. Epub 2015 Dec 8.
citation: Tegeler CH, Tegeler CL, Cook JF, Lee SW, Gerdes L, Shaltout HA, Miles CM, Simpson SL. A Preliminary Study of the Effectiveness of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology in the Treatment of Athletes with Persisting Post-concussion Symptoms. Sports Med Open. 2016 Dec;2(1):39. doi: 10.1186/s40798-016-0063-y. Epub 2016 Sep 14.
citation: Tegeler CH, Cook JF, Tegeler CL, Hirsch JR, Shaltout HA, Simpson SL, Fidali BC, Gerdes L, Lee SW. Clinical, hemispheric, and autonomic changes associated with use of closed-loop, allostatic neurotechnology by a case series of individuals with self-reported symptoms of post-traumatic stress. BMC Psychiatry. 2017 Apr 19;17(1):141. doi: 10.1186/s12888-017-1299-x.