HIRREM in Military Personnel
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/21/2019 |
| Start Date: | February 16, 2015 |
| End Date: | June 2020 |
| Contact: | Study Coordinator |
| Email: | WFHIRREM@wakehealth.edu |
| Phone: | 336-716-9447 |
HIRREM for Mitigation of PTSD Symptoms in Military Personnel
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.
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.
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)
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