Postconcussive Symptoms, PostTraumatic Stress Disorder, Traumatic Brain Injury
Conditions
Keywords
PTSD, Concussion, TBI, TMS, Post Traumatic Stress Disorder, Posttraumatic Stress Disorder, Post-traumatic Stress Disorder, MERT, rTMS, Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Traumatic Brain Injury
Brief summary
The purpose of this study is to evaluate the safety and efficacy of individualized, Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Post-Traumatic Stress Disorder
Detailed description
MERT-005-B is a prospective, double blind, randomized, sham-controlled, parallel group, stratified, adaptive clinical trial designed to evaluate the efficacy of EEG-guided MeRT in persons with Post-Traumatic Stress Disorder A total of 152 participants will be randomized in the Test Phase, and a group-sequential approach to efficacy monitoring by the Data and Safety Monitoring Board (DSMB). A Pilot Phase was completed in which 74 participants were randomized. The Pilot Phase data will be used for confirming the safety of MeRT. For the Test Phase, eligible participants will be randomly assigned to either MeRT or Sham MeRT treatment groups in a 1:1 allocation ratio, with stratification on recruitment site and two levels of PPCS co-morbidity (+/-). Initial eligibility evaluation and data collection will occur at the Screening Visit (SC). Following the SC visit, there will be a 5-week treatment period in which active or sham investigative treatment will be administered during daily weekday visits to the study site. Participants who received sham treatment and who continue to be eligible will be offered up to 25 active MeRT study treatments as part of Open Label Enrollment. Main study outcomes will be collected at the second follow-up visit (F2) at the conclusion of the 5-week treatment period. An abbreviated data collection visit will occur during the third treatment week (the F1 follow-up visit). Additional follow up visits will occur 90 days after the first day of study treatment. Participants, clinicians, and all personnel who participate in evaluation will be blind to study treatment group assignment. The first phase of this trial was conducted in partnership with the United States Special Operations Command (USSOCOM) and the Henry Jackson Foundation.
Interventions
DEVICEActive MeRT Treatment
A personalized biometrics-guided protocol known as magnetic EEG/ECG resonance therapy (MeRT) treatment that is tailored specifically to each participant's EEG intrinsic alpha frequency (IAF). rTMS is applied at the participant's IAF.
DEVICESham MeRT Treatment
rTMS coil does not emit magnetic stimulation.
Sponsors
Texas A&M University
GilpinPhillips BIOMED, LLC
Peachtree BioResearch Solutions
Wave Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet all inclusion criteria to qualify for enrollment in the study: 1. Willing and able to consent to participate in the study 2. Age 18 - 65 years 3. Diagnosis of PTSD according to DSM-V criteria via CAPS-5 4. Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms persisting for a minimum of 6 months prior to the Screening Visit 5. Minimum PCL-5 score of 30
Exclusion criteria
Participants will be excluded from study participation if one or more of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Symptoms | Five weeks | Change in PTSD symptoms as measured by the PTSD Checklist-5 (PCL-5). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcomes - Incidents and types of adverse events | Approximately 3 months | Number and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
Countries
United States
Outcome results
None listed