N/A N=32 Treatment

HIRREM in Military Personnel

Stress Disorders, Post-Traumatic

Bottom Line

View on ClinicalTrials.gov: NCT03230890 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Change in PCL-M Score From Baseline to 12 Days — -12.88 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: HIRREM (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in PCL-M Score From Baseline to 12 Days	-12.88	—
SECONDARY Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score From Baseline to 12 Days	-13.69	—
SECONDARY Change in Insomnia Severity Index (ISI) Score From Baseline to 12 Days	-6.31	—
SECONDARY Change in Generalized Anxiety Disorder-7 (GAD-7) Score From Baseline to 12 Days	-6.69	—
SECONDARY Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) Score From Baseline to 12 Days	-10.70	—
SECONDARY Change in EQ-5D Score From Baseline to 12 Days	9.59	—
SECONDARY Change in Heart Rate Variability Measure of SDNN From Baseline to 12 Days	9.43	—
SECONDARY Change in Baroreflex Sensitivity HF Alpha From Baseline to 12 Days	9.43	—
SECONDARY Change in Baroreflex Sensitivity Sequence Up From Baseline to 12 Days	7.46	—
SECONDARY Change in Baroreflex Sensitivity Sequence Down From Baseline to 12 Days	5.56	—
SECONDARY Change in Baroreflex Sensitivity Sequence All From Baseline to 12 Days	5.75	—
SECONDARY Change in Drop Stick Reaction Time From Baseline to 12 Days	-3.86	—
SECONDARY Change in Grip Strength From Baseline to 12 Days	1.74; 1.94	—
SECONDARY Change in Functional MRI From Baseline to 12 Days	-0.012	—
SECONDARY Change in Blood Biomarkers for Stress and Inflammation Score From Baseline to 12 Days	-0.50; 5.11; -5.87; -29.98; -0.19; -0.20	—
SECONDARY Salivary Biomarker Cortisol for Stress From Baseline to 12 Days	0.04	—
SECONDARY Change in Epigenetic Markers From Baseline to 12 Days	-.00038	—
SECONDARY Change in Sleep Latency Score From Baseline to 42 Days	36.01	—
SECONDARY Change in C-reactive Protein for Stress and Inflammation Score From Baseline to 12 Days	-0.10	—
SECONDARY Salivary Biomarker for Stress From Baseline to 12 Days	15.00	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03230890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.