Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Persistent Post-Concussive Symptoms (PPCS) (MeRT-TBI-005)
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|ClinicalTrials.gov Identifier: NCT02990793|
Recruitment Status : Suspended (Preparing for Phase II.)
First Posted : December 13, 2016
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postconcussive Symptoms Traumatic Brain Injury PostTraumatic Stress Disorder||Device: Active MeRT Treatment Device: Sham MeRT Treatment||Not Applicable|
MeRT-TBI-005 is a prospective, double blind, randomized, sham-controlled, parallel group, adaptive clinical trial designed to evaluate the efficacy of EEG/EKG-guided MeRT in active duty military service men and women, reservists on active duty orders, and military retirees with Persistent Post-Concussion Symptoms (PPCS) and Traumatic Brain Injury. A total of 152 participants will be randomized, with blinded adaptive sample size reassessment up to 250 participants, and a contingent group-sequential single look at interim efficacy data by the Data and Safety Monitoring Board (DSMB).
A Pilot Phase I has completed in which 74 participants were recruited. Phase I will only be used for confirming the safety of MeRT for this indication. For the Test Phase II, 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 PTSD co-morbidity (+/-). Treatment will be initiated on Day 1 of the study, following eligibility evaluation and data collection at the Screening Visit (SC) and Baseline (BL) Visit. Following the SC and BL visits, there will be a 4-week treatment period. Main study outcomes will be collected at the second follow-up visit (F2) at the conclusion of the 4-week treatment period. An abbreviated data collection visit will occur at the conclusion of the second treatment week (the F1 follow-up visit). Participants, clinicians, and all personnel who participate in evaluation, or who interface with treatment protocol downloading software, will be blind to study treatment group assignment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Double-Blind, Randomized, Sham-Controlled, Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment of Persistent Post-Concussive Symptoms (PPCS) Following Traumatic Brain Injury (TBI)|
|Actual Study Start Date :||July 24, 2017|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Active Comparator: Active MeRT Treatment
Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 4 weeks.
Device: Active MeRT Treatment
A personalized biometrics-guided protocol known as magnetic EEG/EKG resonance therapy (MeRT) treatment that is tailored specifically to each patient's higher harmonic frequency of heart rate, which is nearest to the characteristic frequency of alpha EEG frequency.
Other Name: rTMS Active Stimulator
Sham Comparator: Sham MeRT Treatment
Sham treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 4 weeks. Sham treatment mimicks same noise and sensation of active treatment but provides no treatment.
Device: Sham MeRT Treatment
A personalized biometrics-guided protocol similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation.
Other Name: rTMS Sham Stimulator
- Reduction in PPCS [ Time Frame: Four weeks ]Reduction in Persistent Post-Concussion Symptoms; arithmetic reduction in Rivermead Post-Concussion Symptoms Questionnaire (RPQ-16) total severity score between time points SC and F2.
- PTSD Symptom Reduction [ Time Frame: Four weeks ]Reduction in PTSD symptoms will be measured by change in PCL-5 scores between SC and F2 in the subgroup of participants with comorbid PTSD
- Sleep Quality [ Time Frame: Four weeks ]Sleep quality improvement; arithmetic reduction in Pittsburgh Sleep Quality Index (PSQI)
- Safety Outcomes - Incidents and types of adverse events [ Time Frame: Four weeks. ]Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990793
|United States, California|
|Naval Special Warfare|
|San Diego, California, United States, 92103|
|Principal Investigator:||Scott Cota, MD||SOCOM|
|Principal Investigator:||James Chung, DO||Naval Hospital Camp Pendleton|