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

NCT02990793 | Completed DMC FDA Device

• 1 other identifier: MeRT-005-B
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 8

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

Conditions

PostTraumatic Stress Disorder; Traumatic Brain Injury; Postconcussive Symptoms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Symptoms

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

  Five weeks

Other Outcomes (1)

• Safety Outcomes - Incidents and types of adverse events

  Approximately 3 months

Study Arms (2)

Active MeRT Treatment

ACTIVE COMPARATOR

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

Sham MeRT Treatment

SHAM COMPARATOR

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

Interventions

Active MeRT Treatment DEVICE

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.

Also known as: rTMS Active Stimulator

Active MeRT Treatment

Sham MeRT Treatment DEVICE

rTMS coil does not emit magnetic stimulation.

Also known as: rTMS Sham Stimulator

Sham MeRT Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to consent to participate in the study
• Age 18 - 65 years
• Diagnosis of PTSD according to DSM-V criteria via CAPS-5
• Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms persisting for a minimum of 6 months prior to the Screening Visit
• Minimum PCL-5 score of 30

You may not qualify if:

• Index trauma occurred before the age of 16 years
• History of open skull injury
• 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
• History of cerebrovascular accident
• History of cerebral aneurysm
• EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing, or ictal spikes, during the EEG recording
• Inability to calculate the EEG intrinsic alpha frequency at Screening
• Participation in any interventional research protocol within 3 months prior to the Screening Visit
• History of any type of ECT, rTMS, or MeRT treatment
• Treated within 30 days of the Screening Visit with any antipsychotic medication
• Treated within 30 days of the Screening Visit with any benzodiazepine or anticonvulsant medications
• 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

Sponsors & Collaborators

• Wave Neuroscience: lead
• Texas A&M University: collaborator
• GilpinPhillips BIOMED, LLC: collaborator
• Peachtree BioResearch Solutions: collaborator

Study Sites (8)

BrainHealth Solutions

Costa Mesa, California, 92626, United States

Location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

SoCal Neuroscience Research Unit

San Diego, California, 92103, United States

Location

UNC Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Columbus Brain Research Center

Columbus, Ohio, 43219, United States

Location

Center for Interventional Pain and Spine

Bryn Mawr, Pennsylvania, 19010, United States

Location

Texas A&M Research Center

Plano, Texas, 75093, United States

Location

Seattle Neuropsychiatric Treatment Center (Seattle NTC)

Bellevue, Washington, 98004, United States

Location

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• Xia G, Gajwani P, Muzina DJ, Kemp DE, Gao K, Ganocy SJ, Calabrese JR. Treatment-emergent mania in unipolar and bipolar depression: focus on repetitive transcranial magnetic stimulation. Int J Neuropsychopharmacol. 2008 Feb;11(1):119-30. doi: 10.1017/S1461145707007699. Epub 2007 Mar 5.

  PMID: 17335643 BACKGROUND

• Yehuda R. Post-traumatic stress disorder. N Engl J Med. 2002 Jan 10;346(2):108-14. doi: 10.1056/NEJMra012941. No abstract available.

  PMID: 11784878 BACKGROUND

• Yesavage JA, Fairchild JK, Mi Z, Biswas K, Davis-Karim A, Phibbs CS, Forman SD, Thase M, Williams LM, Etkin A, O'Hara R, Georgette G, Beale T, Huang GD, Noda A, George MS; VA Cooperative Studies Program Study Team. Effect of Repetitive Transcranial Magnetic Stimulation on Treatment-Resistant Major Depression in US Veterans: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Sep 1;75(9):884-893. doi: 10.1001/jamapsychiatry.2018.1483.

  PMID: 29955803 BACKGROUND

• Ziemann U. TMS and drugs. Clin Neurophysiol. 2004 Aug;115(8):1717-29. doi: 10.1016/j.clinph.2004.03.006.

  PMID: 15261850 BACKGROUND

• Ziemann U, Reis J, Schwenkreis P, Rosanova M, Strafella A, Badawy R, Muller-Dahlhaus F. TMS and drugs revisited 2014. Clin Neurophysiol. 2015 Oct;126(10):1847-68. doi: 10.1016/j.clinph.2014.08.028. Epub 2014 Dec 4.

  PMID: 25534482 BACKGROUND

• Zwanzger P, Ella R, Keck ME, Rupprecht R, Padberg F. Occurrence of delusions during repetitive transcranial magnetic stimulation (rTMS) in major depression. Biol Psychiatry. 2002 Apr 1;51(7):602-3. doi: 10.1016/s0006-3223(01)01369-5.

  PMID: 11950462 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Kenneth Ramos, MD,PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

• Adele Gilpin, PhD,JD

  GilpinPhillips BIOMED, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: December 13, 2016
• Study Start: April 4, 2022
• Primary Completion: September 18, 2025
• Study Completion: November 4, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)