Status:
COMPLETED
HIRREM in Military Personnel
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Brain State Technologies, LLC
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18+ years
Phase:
NA
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 sympt...
Detailed Description
This will be an open label, single site, pilot, clinical research study. Up to 40 active duty military personnel, or recent Veterans, age 18 or older, who have been diagnosed with PTSD, have received ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 16 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03230890
Start Date
February 16 2015
End Date
April 5 2021
Last Update
August 14 2023
Active Locations (1)
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1
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157