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MeRT-005-B: Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Post-Traumatic Stress Disorder

Sponsor
Wave Neuroscience (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02990793
Collaborator
Texas A&M University (Other), Navitas Clinical Research, Inc (Other), GilpinPhillips BIOMED, LLC (Other)
152
Enrollment
2
Locations
2
Arms
14.9
Anticipated Duration (Months)
76
Patients Per Site
5.1
Patients Per Site Per Month

Study Details

Study Description

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 with and without Persistent Post-Concussive Symptoms (PPCS) following Traumatic Brain Injury (TBI).

Condition or Disease Intervention/Treatment Phase
  • Device: Active MeRT Treatment
  • Device: Sham MeRT Treatment
 N/A

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 with and without Persistent Post-Concussive Symptoms (PPCS) following Traumatic Brain Injury (TBI).

A total of 152 participants will be randomized in the Test Phase, with blinded adaptive sample size reassessment up to 176 participants, 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. All participants who continue to be eligible will be offered 2 additional weeks of active MeRT study treatment.

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 (F3) and 180 days (F4) 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Prospective, Double Blind, Randomized, Sham-Controlled, Clinical Trial to Evaluate The Safety And Efficacy Of Biometrics-Guided Magnetic EEG Resonance Therapy (MeRT) Treatment Of Post-Traumatic Stress Disorder With And Without Persistent Post-Concussive Symptoms (PPCS) Following Traumatic Brain Injury (TBI)
Actual Study Start Date :
Apr 4, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active MeRT Treatment

Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 5 weeks.

Device: Active 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.
Other Names:
  • 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 5 weeks.

    Device: Sham MeRT Treatment
    rTMS coil does not emit magnetic stimulation.
    Other Names:
  • rTMS Sham Stimulator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in PTSD Symptoms [Five weeks]

      Change in PTSD symptoms as measured by the PTSD Checklist-5 (PCL-5).

    Secondary Outcome Measures

    1. Change in PPCS [Five weeks]

      Change in Persistent Post-Concussion Symptoms as measured by reduction in Rivermead Post-Concussion Symptoms Questionnaire (RPQ-16) total severity score in the subset of participants with PPCS following TBI.

    Other Outcome Measures

    1. Safety Outcomes - Incidents and types of adverse events [Approximately 6 months]

      Number and type of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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 exclusion criteria apply:

    1. Index trauma occurred before the age of 16 years

    2. History of open skull injury

    3. History of a neurological disorder including, but not limited to:

    • Seizure disorder

    • Any condition likely to be associated with increased intracranial pressure

    • Space occupying brain lesion

    1. History of cerebrovascular accident

    2. History of cerebral aneurysm

    3. EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing, or ictal spikes, during the EEG recording

    4. Inability to calculate the EEG intrinsic alpha frequency at Screening

    5. Participation in any interventional research protocol within 3 months prior to the Screening Visit

    6. History of any type of ECT, rTMS, or MeRT treatment

    7. Treated within 30 days of the Screening Visit with any antipsychotic medication

    8. Treated within 30 days of the Screening Visit with any benzodiazepine or anticonvulsant medications

    9. Current treatment with any restricted concomitant medication (i.e., NDRI, SSRI, SNRI, or QBDZ) that has not been stable for the preceding 60 days at the time of the Screening Visit

    10. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within the head, excluding the mouth, or on the head, that cannot be safely removed

    11. Biomedical devices, including those not in or on the head, that are either implanted or not safe to remove, that may be affected by the magnetic field of the stimulator (e.g., cardiac pacemaker, cardioverter defibrillator (ICD), or medication dispensing device)

    12. Clinically significant medical illness or condition, including, but not limited to, any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunction, or chronic excessive alcohol consumption, that in the Investigator's judgment might pose a potential safety risk to the participant or limit the interpretation of trial results

    13. Pregnant, or female unwilling to use effective birth control during the course of the trial

    14. Plan to move away from the area, or knowledge that there will be an absence from the area, within 80 days following the Screening Visit (inclusive)

    15. Unwilling or unable to adhere to the study treatment, data collection schedule, or study procedures, or any condition, including inability to communicate in English, which in the judgment of the Investigator might prevent the participant from completing the study, render study results uninterpretable, or represent an unacceptable safety risk to the participant or study personnel that is not otherwise listed in exclusion criteria.

    16. Clinically significant psychopathology, including, but not limited to, schizophrenia or bipolar disorder, or other psychiatric disorder that in the Investigator's judgment might pose a potential safety risk to the participant, or limit the interpretation of trial results

    17. An elevated risk of suicide or violence to others

    18. Current psychotherapeutic treatment, expected to continue throughout the trial, that was begun in the preceding 60 days at the time of the Screening Visit

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SoCal Neuroscience Research Unit San Diego California United States 92103
    2 Texas A&M Research Center Dallas Texas United States 75246

    Sponsors and Collaborators

    • Wave Neuroscience
    • Texas A&M University
    • Navitas Clinical Research, Inc
    • GilpinPhillips BIOMED, LLC

    Investigators

    • Principal Investigator: Kenneth Ramos, MD,PhD, Texas A&M University
    • Study Chair: Adele Gilpin, PhD,JD, GilpinPhillips BIOMED, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Wave Neuroscience
    ClinicalTrials.gov Identifier:
    NCT02990793
    Other Study ID Numbers:
    • MeRT-005-B
    First Posted:
    Dec 13, 2016
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Wave Neuroscience
    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
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Post-Concussion Syndrome
    Disease
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Jun 24, 2022