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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990793
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : June 24, 2022
Sponsor:
Collaborators:
Texas A&M University
Navitas Clinical Research, Inc
GilpinPhillips BIOMED, LLC
Information provided by (Responsible Party):
Wave Neuroscience

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
PostTraumatic Stress Disorder Traumatic Brain Injury Postconcussive Symptoms Device: Active MeRT Treatment Device: Sham MeRT Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 4, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: rTMS Sham Stimulator




Primary Outcome Measures :
  1. Change in PTSD Symptoms [ Time Frame: Five weeks ]
    Change in PTSD symptoms as measured by the PTSD Checklist-5 (PCL-5).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990793


Contacts
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Contact: Adele Gilpin, PhD,JD 949-229-2869 mert005b@gmail.com
Contact: Meagan Kovacs, MSc 949-229-2869

Locations
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United States, California
SoCal Neuroscience Research Unit Recruiting
San Diego, California, United States, 92103
Contact: Bibiana Gonzalez    619-488-9781      
Contact: Nishat Vemuri    (619) 488-9781      
Principal Investigator: James Chung, DO         
United States, Texas
Texas A&M Research Center Recruiting
Dallas, Texas, United States, 75246
Contact: McKenna Lasher, BS    214-828-8291    dallas.coordinator@mertptsdtrial.com   
Principal Investigator: Spencer O Miller, MD         
Sponsors and Collaborators
Wave Neuroscience
Texas A&M University
Navitas Clinical Research, Inc
GilpinPhillips BIOMED, LLC
Investigators
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Principal Investigator: Kenneth Ramos, MD,PhD Texas A&M University
Study Chair: Adele Gilpin, PhD,JD GilpinPhillips BIOMED, LLC
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Madulara, M. D., Francisco, P. A., Nawang, S., Arogancia, D. C., Cellucci, C. J., Rapp, P. E., & Albano, A. M. (2012). EEG transfer entropy tracks changes of information transfer on the onset of vision. International Journal of Modern Physics, 17, 9-18.
Mayo Clinic Staff. (n.d.). Post-concussion syndrome. Retrieved September 15, 2015, from Mayo Clinic: http://www.mayoclinic.org/diseases-conditions/post-concussion-syndrome/basics/treatment/con-20032705
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Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmöller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24. Review.
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Responsible Party: Wave Neuroscience
ClinicalTrials.gov Identifier: NCT02990793    
Other Study ID Numbers: MeRT-005-B
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: 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:
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Brain Injuries
Brain Injuries, Traumatic
Post-Concussion Syndrome
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Trauma and Stressor Related Disorders
Mental Disorders
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating