HIRREM in Military Personnel

NCT03230890 | Completed Results FDA Device

• 1 other identifier: IRB00028990
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects associated with the use of in-office High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) for participants with symptoms of military-related traumatic stress. This is a single site, non-randomized, open label pilot study. Outcome measures collected before, and after the intervention evaluate effects on self-reported symptoms, autonomic cardiovascular regulation, functional measures, blood and saliva biomarkers of stress and inflammation, and network connectivity on whole brain, rest MRI testing. Self-reported symptom outcomes will also be collected remotely at 1, 3, and 6 months after completion of intervention. The study will assess feasibility in this cohort, focused on the Special Operations community, will provide estimates of effect size, and durability of symptom changes, while providing important pilot data for future proposals and investigations.

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD; military; neurotechnology; HIRREM; allostasis; heart rate variability; baroreflex sensitivity; closed loop; acoustic stimulation; neural oscillations; autonomic; hyperarousal

Outcome Measures

Primary Outcomes (1)

• Change in PCL-M Score From Baseline to 12 Days

  The PTSD Checklist (PCL) - Military (M) is a symptom checklist to measure stress severity due to a traumatic experience in military settings. The PCL-M measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) of PTSD symptoms based on traumatic life experience. Seventeen items are rated on a Likert scale from 1 (not at all) to 5 (extremely), with a total score ranging from 17 to 85. Higher scores suggest more PTSD symptoms. Primary outcome for this pilot study will be change in PCL-M score from baseline to the immediate post-intervention in-person data collection at the completion of the HIRREM intervention (up to 12 days later).

  Data is collected at baseline and immediately following completion of the HIRREM intervention (up to 12 days later)

Secondary Outcomes (19)

• Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score From Baseline to 12 Days

  Data is collected at baseline and immediately following completion of the intervention (up to 12 days later)

• Change in Insomnia Severity Index (ISI) Score From Baseline to 12 Days

  Data is collected at baseline and immediately following completion of the intervention (up to 12 days later)

• Change in Generalized Anxiety Disorder-7 (GAD-7) Score From Baseline to 12 Days

  Data is collected at baseline and immediately following completion of the intervention (up to 12 days later)

• Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) Score From Baseline to 12 Days

  Data is collected at baseline and immediately following completion of the intervention (up to 12 days later)

• Change in EQ-5D Score From Baseline to 12 Days

  Data is collected at baseline and immediately following completion of the intervention (up to 12 days later)

Study Arms (1)

HIRREM

EXPERIMENTAL

This is the intervention, treatment arm that all participants receive in this open label, single arm trial. The intervention is High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM).

Device: HIRREM

Interventions

HIRREM DEVICE

HIRREM is a closed-loop, allostatic, acoustic stimulation neurotechnology intended to support auto-calibration of neural oscillations. The core technology is commercially available as a technique for relaxation. Scalp sensors monitor brain frequencies and amplitudes, and in real time, software algorithms translate specific frequencies into audible tones of varying pitch. These are reflected via earbuds in as little as 4-8 milliseconds. The in-office intervention for this study is administered as a series of up to twenty four, typically 1.5-2 hours sessions, comprised of 4-10 protocols (some eyes open, some eyes closed), lasting 6-40 minutes each, working at different scalp locations. Sessions are received over 12 days. Two sessions can be done in a half day. The intervention is received while comfortably seated in a zero gravity chair.

HIRREM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active duty military personnel, or recent veterans (Operation Enduring Freedom, Operation Iraqi Freedom, or Operation New Dawn), men and women, with a diagnosis of PTSD, or active symptoms suggesting PTSD as identified by a screening PCL-M score of 50 or greater, with or without traumatic brain injury (TBI), are eligible to participate in the study.

You may not qualify if:

• Unable, unwilling, or incompetent to provide informed consent
• Physically unable to come to the study visits, or to sit in a chair for several hours
• Known seizure disorder
• Severe hearing impairment (because the subject will be using ear buds during HIRREM)
• Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications (SSRI, or SNRI's), sleep medications such as zolpidem or eszopiclone, stimulants such as Adderall, Provigil, or Ritalin, or thyroid hormone
• Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
• Lack of internet or smart phone access (will maintain remote access daily sleep diary through 1 month post-HIRREM visit)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Brain State Technologies, LLC: collaborator

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (9)

• 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.

  PMID: 28420362 BACKGROUND

• 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.

  PMID: 27747793 BACKGROUND

• 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.

  PMID: 26645307 BACKGROUND

• 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.

  PMID: 26347688 BACKGROUND

• 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.

  PMID: 26085968 BACKGROUND

• 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.

  PMID: 25668305 BACKGROUND

• 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.

  PMID: 25136325 BACKGROUND

• 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.

  PMID: 23532171 BACKGROUND

• Tegeler CL, Gerdes L, Shaltout HA, Cook JF, Simpson SL, Lee SW, Tegeler CH. Successful use of closed-loop allostatic neurotechnology for post-traumatic stress symptoms in military personnel: self-reported and autonomic improvements. Mil Med Res. 2017 Dec 22;4(1):38. doi: 10.1186/s40779-017-0147-0.

  PMID: 29502530 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Charles H. Tegeler, MD
• Organization: Atrium Health Wake Forest Baptist

BBRP@wakehealth.edu

336-716-9447

Study Officials

• Charles H Tegeler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site, non-randomized, single arm, open label design,with collection of outcome measures before, and at intervals after the intervention

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 27, 2017
• Study Start: February 16, 2015
• Primary Completion: April 1, 2021
• Study Completion: April 5, 2021
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)