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PostTraumatic Stress DisorderMeRT-005-BNCT02990793

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

A study testing Active MeRT Treatment in people with PostTraumatic Stress Disorder and Traumatic Brain Injury, run by Wave Neuroscience at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Active MeRT Treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
8 sitesUnited States
Study dates
4 Apr 2022to 4 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all inclusion criteria to qualify for enrollment in the study:
  • 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

Who cannot join

  • Participants will be excluded from study participation if one or more of the following exclusion criteria apply:
  • 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
Show all 25Show fewer
  • 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
  • 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
  • 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)
  • 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
  • Pregnant, or female unwilling to use effective birth control during the course of the trial
  • 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)
  • 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.
  • 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
  • An elevated risk of suicide or violence to others
  • Current psychotherapeutic treatment, expected to continue throughout the trial, that was begun in the preceding 60 days at the time of the Screening Visit

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites
  • Seattle Neuropsychiatric Treatment Center (Seattle NTC)

    Bellevue, Washington, 98004

  • Center for Interventional Pain and Spine

    Bryn Mawr, Pennsylvania, 19010

  • Columbus Brain Research Center

    Columbus, Ohio, 43219

  • BrainHealth Solutions

    Costa Mesa, California, 92626

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Texas A&M Research Center

    Plano, Texas, 75093

  • UNC Rex Hospital

    Raleigh, North Carolina, 27607

  • SoCal Neuroscience Research Unit

    San Diego, California, 92103

Other trials in United States

About this study

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

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

Read the 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, 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 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.

Being tested
Active MeRT Treatment, Sham MeRT Treatment
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
Medical subject headings
Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic, Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active MeRT TreatmentDevice

    Also called rTMS Active Stimulator

    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.

  • Sham MeRT TreatmentDevice

    Also called rTMS Sham Stimulator

    rTMS coil does not emit magnetic stimulation.

Study groups in NCT02990793
Study groupRoleWhat they receive
Active MeRT TreatmentActive comparatorActive treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 5 weeks.
Receives: Device: Active MeRT Treatment
Sham MeRT TreatmentSham comparatorSham treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 5 weeks.
Receives: Device: Sham MeRT Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in PTSD Symptoms

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

    Measured: Five weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2016 (estimated)
  2. Study start4 Apr 2022
  3. Primary completion18 Sep 2025
  4. Study completion4 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02990793
Sponsor's protocol ID
MeRT-005-B
Acronym
MeRT-005-B
Status last verified
Jan 2026
First submitted
10 Nov 2016
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Abelson JL, Curtis GC, Sagher O, Albucher RC, Harrigan M, Taylor SF, Martis B, Giordani B. Deep brain stimulation for refractory obsessive-compulsive disorder. Biol Psychiatry. 2005 Mar 1;57(5):510-6. doi: 10.1016/j.biopsych.2004.11.042.

    PubMed 15737666
  • Achard S, Delon-Martin C, Vertes PE, Renard F, Schenck M, Schneider F, Heinrich C, Kremer S, Bullmore ET. Hubs of brain functional networks are radically reorganized in comatose patients. Proc Natl Acad Sci U S A. 2012 Dec 11;109(50):20608-13. doi: 10.1073/pnas.1208933109. Epub 2012 Nov 26.

    PubMed 23185007
  • ACRM: Mild Traumatic Brain Injury Committee. (1993). Definition of mild traumatic brain injury. J Head Trauma Rehabil, 8, 86-87.

  • American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders (5th ed.). Washington, DC: American Psychiatric Publishing.

  • American Psychiatric Association. (2013). PTSD: National Center for PTSD. Retrieved October 12, 2020, from U.S. Department of Veterans Affairs: https://www.ptsd.va.gov/professional/treat/essentials/

  • American Psychiatric Association Task Force on DSM-IV. (2000). Diagnostic and statistical manual of mental disorders: DSM-IV-TR. 4th ed. Washington, DC: American Psychiatric Association.

  • Anderson B, Mishory A, Nahas Z, Borckardt JJ, Yamanaka K, Rastogi K, George MS. Tolerability and safety of high daily doses of repetitive transcranial magnetic stimulation in healthy young men. J ECT. 2006 Mar;22(1):49-53. doi: 10.1097/00124509-200603000-00011.

    PubMed 16633208
  • Arciniegas DB, Silver JM. Regarding the search for a unified definition of mild traumatic brain injury. Brain Inj. 2001 Jul;15(7):649-52. doi: 10.1080/02699050010019800. No abstract available.

    PubMed 11429094
  • Bae EH, Schrader LM, Machii K, Alonso-Alonso M, Riviello JJ Jr, Pascual-Leone A, Rotenberg A. Safety and tolerability of repetitive transcranial magnetic stimulation in patients with epilepsy: a review of the literature. Epilepsy Behav. 2007 Jun;10(4):521-8. doi: 10.1016/j.yebeh.2007.03.004. Epub 2007 May 9.

    PubMed 17493877
  • Bang, H., Flaherty, S. P., Kolahi, J., & Park, J. (2010). Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol. Clinical Research and Regulatory Affairs, 27(2), 42 - 51.

  • Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.

    PubMed 15020033
  • Benjet C, Bromet E, Karam EG, Kessler RC, McLaughlin KA, Ruscio AM, Shahly V, Stein DJ, Petukhova M, Hill E, Alonso J, Atwoli L, Bunting B, Bruffaerts R, Caldas-de-Almeida JM, de Girolamo G, Florescu S, Gureje O, Huang Y, Lepine JP, Kawakami N, Kovess-Masfety V, Medina-Mora ME, Navarro-Mateu F, Piazza M, Posada-Villa J, Scott KM, Shalev A, Slade T, ten Have M, Torres Y, Viana MC, Zarkov Z, Koenen KC. The epidemiology of traumatic event exposure worldwide: results from the World Mental Health Survey Consortium. Psychol Med. 2016 Jan;46(2):327-43. doi: 10.1017/S0033291715001981. Epub 2015 Oct 29.

    PubMed 26511595
  • Bikson M, Hanlon CA, Woods AJ, Gillick BT, Charvet L, Lamm C, Madeo G, Holczer A, Almeida J, Antal A, Ay MR, Baeken C, Blumberger DM, Campanella S, Camprodon JA, Christiansen L, Loo C, Crinion JT, Fitzgerald P, Gallimberti L, Ghobadi-Azbari P, Ghodratitoostani I, Grabner RH, Hartwigsen G, Hirata A, Kirton A, Knotkova H, Krupitsky E, Marangolo P, Nakamura-Palacios EM, Potok W, Praharaj SK, Ruff CC, Schlaug G, Siebner HR, Stagg CJ, Thielscher A, Wenderoth N, Yuan TF, Zhang X, Ekhtiari H. Guidelines for TMS/tES clinical services and research through the COVID-19 pandemic. Brain Stimul. 2020 Jul-Aug;13(4):1124-1149. doi: 10.1016/j.brs.2020.05.010. Epub 2020 May 12.

    PubMed 32413554
  • Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.

    PubMed 17636720
  • Bjork JM, Burroughs TK, Franke LM, Pickett TC, Johns SE, Moeller FG, Walker WC. Laboratory impulsivity and depression in blast-exposed military personnel with post-concussion syndrome. Psychiatry Res. 2016 Dec 30;246:321-325. doi: 10.1016/j.psychres.2016.10.008. Epub 2016 Oct 7.

    PubMed 27750113

Questions about this trial

What is this clinical trial studying?

A study testing Active MeRT Treatment in people with PostTraumatic Stress Disorder and Traumatic Brain Injury, run by Wave Neuroscience at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PTSD Symptoms (time frame: Five weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02990793, which also lists 171 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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