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

February 29, 2024 updated by: Wave Neuroscience

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, 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. 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 (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 Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Terminated
        • SoCal Neuroscience Research Unit
    • Ohio
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
    • Texas
      • Plano, Texas, United States, 75093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  4. History of cerebrovascular accident
  5. History of cerebral aneurysm
  6. EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing, or ictal spikes, during the EEG recording
  7. Inability to calculate the EEG intrinsic alpha frequency at Screening
  8. Participation in any interventional research protocol within 3 months prior to the Screening Visit
  9. History of any type of ECT, rTMS, or MeRT treatment
  10. Treated within 30 days of the Screening Visit with any antipsychotic medication
  11. Treated within 30 days of the Screening Visit with any benzodiazepine or anticonvulsant medications
  12. 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
  13. 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
  14. 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)
  15. 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
  16. Pregnant, or female unwilling to use effective birth control during the course of the trial
  17. 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)
  18. 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.
  19. 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
  20. An elevated risk of suicide or violence to others
  21. Current psychotherapeutic treatment, expected to continue throughout the trial, that was begun in the preceding 60 days at the time of the Screening Visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PTSD Symptoms
Time Frame: Five weeks
Change in PTSD symptoms as measured by the PTSD Checklist-5 (PCL-5).
Five weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PPCS
Time Frame: 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.
Five weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Outcomes - Incidents and types of adverse events
Time Frame: Approximately 6 months
Number and type of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wave Neuroscience

Collaborators

Texas A&M University
GilpinPhillips BIOMED, LLC
Peachtree BioResearch Solutions

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimated)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MeRT-005-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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