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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 : March 1, 2024
Sponsor:
Collaborators:
Texas A&M University
GilpinPhillips BIOMED, LLC
Peachtree BioResearch Solutions
Information provided by (Responsible Party):
Wave Neuroscience

Study Description
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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

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

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 Design
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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
Actual Study Start Date : April 4, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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).


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)


Eligibility Criteria
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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
Contacts and Locations
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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: Mazaya Soundara, BS 949-229-2869 mazaya@waveneuro.com

Locations
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United States, California
SoCal Neuroscience Research Unit Terminated
San Diego, California, United States, 92103
United States, Ohio
Columbus Brain Research Center Not yet recruiting
Columbus, Ohio, United States, 43219
Contact: Erin Woodburn    330-340-5988    erin@mertptrsdtrial.com   
Contact       oh.coordinator@mertptsdtrial.com   
Principal Investigator: Walter Mysiw, MD         
United States, Pennsylvania
Center for Interventional Pain and Spine Not yet recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Ashley Scherer    302-750-3099    ashleys@mertptsdtrial.com   
Contact       pa.coordinator@mertptsdtrial.com   
Principal Investigator: Phillip Kim, DO         
Sub-Investigator: Justin Winas, DO         
United States, Texas
Texas A&M Research Center Recruiting
Plano, Texas, United States, 75093
Contact: Erycha Butler    214-828-8436    dallas.coordinator@mertptsdtrial.com   
Principal Investigator: Spencer O Miller, MD         
Sponsors and Collaborators
Wave Neuroscience
Texas A&M University
GilpinPhillips BIOMED, LLC
Peachtree BioResearch Solutions
Investigators
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Principal Investigator: Kenneth Ramos, MD,PhD Texas A&M University
Study Chair: Adele Gilpin, PhD,JD GilpinPhillips BIOMED, LLC
More Information
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Publications:
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.
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.
CONSORT Group. (2010). CONSORT 2010. Retrieved January 13, 2016, from CONSORT Transparent Reporting of Trials: http://www.consort-statement.org/consort-2010
Department of Defense. (2011, November). Department of Defense Instruction 3216.02.
Dupont, W. D., & Plummer, W. D. (1997). Power and Sample Size software. Controlled Clinical Trials, 18, 274.
Eckberg, D. L. (2004). Correlations among heart rate variability components and autonomic mechanisms. In M. Malik, & J. A. Camm (Eds.), Dynamic Electrocardiology (pp. 31-39). Elmsford, NY, US: Blackwell/Futura.
Evidence-based Synthesis Program (ESP) Center, Portland VA Medical Center. (2015, November). Systematic Review of Suicide Prevention in Veterans. Retrieved October 24, 2020, from U.S. Department of Veterans Affairs: https://www.hsrd.research.va.gov/publications/esp/SuicidePrevention-REPORT.pdf
International Committee of Medical Journal Editors. (2015, December). Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Retrieved February 24, 2016, from 2016 International Committee of Medical Journal editors: www.icmje.org
Johns, M. (n.d.). About the ESS. Retrieved October 23, 2020, from The Epworth Sleepiness Scale: https://epworthsleepinessscale.com/about-the-ess/
Keane, T. M., Fairbank, J. A., Caddel, J. M., Zimering, R. T., Taylor, K. L., & Mora, C. A. (1989). Clinical Evaluation of a Measure to Assess Combat Exposure. Psychological Assessment, 1(1), 53 - 55.
Kroenke, K., & Spitzer, R. L. (2002, September). The PHQ-9: A New Depression Diagnostic and Severity Measure. Psychiatric Annals, 32(9), 1 - 7.
Lopes da Silva, F. (2005(a)). EEG analysis: theory and practice. In E. Niedermeyer, & F. Lopes da Silva (Eds.), Electroencephalography; Basic Principles, Clinical Applications and Related Fields (pp. 1199-1231). Philadelphia, PA, USA: Lippincott, Williams and Wilkins.
Lopes da Silva, F. (2005(b)). Events-related potentials: methodology and quantification. In E. Niedermeyer, & F. Lopes da Silva, Electroencephalography: Basic Principles, Clinical Applications and Related Fields (pp. 991-1001). Philadelphia, Pennsylvania, US: Lippincott, Williams and Wilkins.
Luck, S. J. (2005). An Introduction to the Event-Related Potential Technique. Cambridge, MA, US: MIT Press.
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
McCrea, M, ed; American Academy of Clinical Neuropsychology. (2008). Mild traumatic brain injury and postconcussion syndrome: the new evidence base for diagnosis and treatment. Oxford; New York: Oxford University Press.
Miller, M. W., Wolf, E. J., Kilpatrick, D., Resnick, H., Marx, B. P., Holowka, D. W., . . . Friedman, M. J. (2012). The Prevalence and Latent Structure of Proposed DSM-5 Posttraumatic Stress Disorder Symptoms in U.S. National and Veteran Samples. Psychological Trauma: Theory, Research, Practice, and Policy. doi:10.1037/a0029730
Nintendo of America Inc. (2015). Nintendo Gameboy Manual. Redmond, WA.
Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller 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.
Spencer, K. M. (2005). Averaging, detection and classification of single-trial ERPs. In T. M. Handy (Ed.), Event Related Potentials. A Methods Handbook (pp. 209-227). Cambridge, MA, US: MIT Press.
Tanelian, T L; Jaycox, L, eds. (2008). Invisible wounds of war: psychological and cognitive injuries, their consequences, and services to assist recovery. RAND Center for Military Health Policy Research. Santa Monica, CA: RAND Corporation.
The Columbia Protocol: About the Protocol. (2016). Retrieved October 24, 2020, from The Columbia Lighthouse Project: Identify Risk, Prevent Suicide: https://cssrs.columbia.edu/the-columbia-scale-c-ssrs/about-the-scale/
The Ohio State University Wexner Medical Center. (2020). Ohio State University TBI Identification Method. Retrieved October 23, 2020, from The Ohio State University Wexner Medical Center: https://wexnermedical.osu.edu/neurological-institute/departments-and-centers/research-centers/ohio-valley-center-for-brain-injury-prevention-and-rehabilitation/osu-tbi-id
Thompson, C., Davies, P., Herrmann, L., Summers, M., & Potter, S. (2016, March). Approaches to establishing validated cut-off scores on the Rivermead Post Concussion Symptoms Questionnaire (RPQ). Brain Injury, 30(5-6), 770.
U.S. Department of Veterans Affairs. (2015, December 3). PTSD Checklist for DSM-5 (PCL-5). Retrieved from U.S. Department of Veterans Affairs PTSD: National Center for PTSD: http://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp
U.S. Department of Veterans Affairs. (2020, August 10). Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Retrieved 10 19, 2020, from PTSD: National Center for PTSD: https://www.ptsd.va.gov/professional/assessment/adult-int/caps.asp
U.S. Department of Veterans Affairs. (2020, June 9). PTSD Checklist for DSM-5 (PCL-5). Retrieved July 13, 2020, from PTSD: National Center for PTSD: https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp
United States Army Medical Command. (2014, March 4). OSTG/MEDCOM Policy Memo 14-019. Inpatient and Emergency Department (ED) Aftercare; MEMORANDUM FOR COMMANDERS, MEDCOM REGIONAL MEDICAL COMMANDS. JBSA Fort Sam Houston, Texas, USA.
United States Department of Veterans Affairs. (2020, August 10). Combat Exposure Scale (CES). Retrieved October 24, 2020, from National Center for PTSD: https://www.ptsd.va.gov/professional/assessment/te-measures/ces.asp
United States Food and Drug Administration. (2012). Guidance for Industry; Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials (Draft Guidance). Center for Drug Evaluation and Research (CDER). Retrieved October 24, 2020, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-suicidal-ideation-and-behavior-prospective-assessment-occurrence-clinical-trials
United States Food and Drug Administration. (July 27, 2016). Guidance: Adaptive Designs for Medical Device Clinical Studies. Rockville, MD: U.S. FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research.
University of Pittsburgh. (2020, October 23). Measures and Study Instruments. Retrieved from University of Pittsburgh Center for Sleep and Circadian Science: https://www.sleep.pitt.edu/instruments/#psqi
Van Etten ML, et. al. (1998). Comparative Efficacy of Treatements for Post-traumatic Stress Disorder: A Meta-Analysis. Clin Psychol. Psychother, 5, 126-144.
Waite, J. C. (2017). Assessing Blinding in Randomized Clinical Trials. Masters Thesis in Mathematics;. California State Polytechnic University. Retrieved from http://dspace.calstate.edu/bitstream/handle/10211.3/196699/WaiteJesse_Thesis2017.pdf?sequence=6
Weathers et. al. (2020, March 12). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). [Assessment]. Retrieved March 17, 2020, from U.S. Department of Veterans Affairs: PTSD: National Center for PTSD: www.ptsd.va.gov
Weathers, F. W., Blake, D. D., Schnurr, P. P., Kaloupek, D. G., Marx, B. P., & Keane, T. M. (2020, September 29). PTSD: National Center for PTSD. Retrieved 10 19, 2020, from U.S. Department of Veterans Affairs: https://www.ptsd/valgov/professional/assessment/te-measures/life_events_checklist.aspl
World Health Organization, editors. (1993). The ICD-10 Classification of Mental and Behavioural Disorders Diagnostic Criteria for Research. Geneva: World Health Organization.

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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: March 1, 2024
Last Verified: February 2024
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
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating