Evaluating MeRT Treatment for Post-Traumatic Stress Disorder

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

This study is testing a new therapy called MeRT to see if it can help people with Post-Traumatic Stress Disorder feel better over five weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Wave Neuroscience (industry)
• Locations: 8 sites (Costa Mesa, California and 7 other locations)
• Trial ID: NCT02990793 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of Biometrics-guided Magnetic e-Resonance Therapy (MeRT) for individuals diagnosed with Post-Traumatic Stress Disorder (PTSD). The study involves a double-blind, randomized, sham-controlled design, where participants will be assigned to either active MeRT or sham treatment over a 5-week period. A total of 152 participants will be enrolled, with outcomes monitored by a Data and Safety Monitoring Board. The trial includes a pilot phase that confirmed the safety of MeRT, and participants will undergo follow-up assessments to evaluate treatment effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with a diagnosis of PTSD persisting for at least 6 months.

Not a fit: Patients with a history of neurological disorders or those whose index trauma occurred before age 16 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for individuals suffering from PTSD.

How similar studies have performed: Other studies have shown promise with similar EEG-guided therapies, suggesting potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Costa Mesa, California and 7 other locations

• BrainHealth Solutions — Costa Mesa, California, United States (RECRUITING)
• VA Long Beach Healthcare System — Long Beach, California, United States (RECRUITING)
• SoCal Neuroscience Research Unit — San Diego, California, United States (TERMINATED)
• UNC Rex Hospital — Raleigh, North Carolina, United States (RECRUITING)
• Columbus Brain Research Center — Columbus, Ohio, United States (RECRUITING)
• Center for Interventional Pain and Spine — Bryn Mawr, Pennsylvania, United States (RECRUITING)
• Texas A&M Research Center — Plano, Texas, United States (RECRUITING)
• Seattle Neuropsychiatric Treatment Center (Seattle NTC) — Bellevue, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Kenneth Ramos, MD,PhD — Texas A&M University
• Study coordinator: Adele Gilpin, PhD,JD

Conditions: PostTraumatic Stress Disorder, Traumatic Brain Injury, Postconcussive Symptoms, PTSD, Concussion, TBI, TMS, Post Traumatic Stress Disorder