Last updated on February 2018

Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Persistent Post-Concussive Symptoms (PPCS)

Brief description of study

The purpose of this study is to evaluate the safety and efficacy of individualized, Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Persistent Post-Concussive Symptoms (PPCS) following Traumatic Brain Injury (TBI).

Detailed Study Description

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 150 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).

Participants will be recruited from military bases, and their vicinities, in two locations. 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.

Clinical Study Identifier: NCT02990793

Contact Investigators or Research Sites near you

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James Chung, DO

Naval Special Warfare
San Diego, CA United States
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Scott Cota, MD

MacDill Air Force Base
Macdill Air Force Base, FL United States
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