ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Persistent Post-Concussive Symptoms (PPCS) (MeRT-TBI-005)

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 : November 8, 2017
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
U.S. Special Operations Command
Henry M. Jackson Foundation for the Advancement of Military Medicine
KAI Research
Information provided by (Responsible Party):
Newport Brain Research Laboratory

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 Persistent Post-Concussive Symptoms (PPCS) following Traumatic Brain Injury (TBI).

Condition or disease Intervention/treatment Phase
Postconcussive Symptoms Traumatic Brain INjury PostTraumatic Stress Disorder Device: Active MeRT Treatment Device: Sham MeRT Treatment Not Applicable

Detailed Description:

MeRT-TBI-005 is a prospective, double blind, randomized, sham-controlled, parallel group, adaptive clinical trial designed to evaluate the efficacy of EEG/EKG-guided MeRT in active duty military service men and women, reservists on active duty orders, and military retirees with Persistent Post-Concussion Symptoms (PPCS) and Traumatic Brain Injury. A total of 150 participants will be randomized, with blinded adaptive sample size reassessment up to 250 participants, and a contingent group-sequential single look at interim efficacy data by the Data and Safety Monitoring Board (DSMB).

Participants will be recruited from military bases, and their vicinities, in two locations. 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 PTSD co-morbidity (+/-). Treatment will be initiated on Day 1 of the study, following eligibility evaluation and data collection at the Screening Visit (SC) and Baseline (BL) Visit. Following the SC and BL visits, there will be a 4-week treatment period. Main study outcomes will be collected at the second follow-up visit (F2) at the conclusion of the 4-week treatment period. An abbreviated data collection visit will occur at the conclusion of the second treatment week (the F1 follow-up visit). Participants, clinicians, and all personnel who participate in evaluation, or who interface with treatment protocol downloading software, will be blind to study treatment group assignment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Double-Blind, Randomized, Sham-Controlled, Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment of Persistent Post-Concussive Symptoms (PPCS) Following Traumatic Brain Injury (TBI)
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

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 4 weeks.
Device: Active MeRT Treatment
A personalized biometrics-guided protocol known as magnetic EEG/EKG resonance therapy (MeRT) treatment that is tailored specifically to each patient's higher harmonic frequency of heart rate, which is nearest to the characteristic frequency of alpha EEG frequency.
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 4 weeks. Sham treatment mimicks same noise and sensation of active treatment but provides no treatment.
Device: Sham MeRT Treatment
A personalized biometrics-guided protocol similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation.
Other Name: rTMS Sham Stimulator




Primary Outcome Measures :
  1. Reduction in PPCS [ Time Frame: Four weeks ]
    Reduction in Persistent Post-Concussion Symptoms; arithmetic reduction in Rivermead Post-Concussion Symptoms Questionnaire (RPQ-16) total severity score between time points SC and F2.


Secondary Outcome Measures :
  1. PTSD Symptom Reduction [ Time Frame: Four weeks ]
    Reduction in PTSD symptoms will be measured by change in PCL-5 scores between SC and F2 in the subgroup of participants with comorbid PTSD


Other Outcome Measures:
  1. Sleep Quality [ Time Frame: Four weeks ]
    Sleep quality improvement; arithmetic reduction in Pittsburgh Sleep Quality Index (PSQI)

  2. Safety Outcomes - Incidents and types of adverse events [ Time Frame: Four weeks. ]
    Arithmetic number 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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

  1. Willing and able to consent to participate in the study
  2. Active duty, reservist on active duty orders, National Guard on active duty orders, or military retiree, United States military service men and women
  3. Age 18 - 55 years
  4. TBI according to the following American Congress of Rehabilitation Medicine (ACRM) criteria for mTBI, excepting that the severity of injury associated with focal neurological deficit(s) may exceed the ACRM criteria for mild injury:

    Sustaining of a traumatically induced physiological disruption of brain function, as manifested by at least one of the following -

    • Any period of loss of consciousness
    • Any loss of memory for events immediately before or after the accident
    • Any alteration in mental state at the time of the accident
    • Focal neurological deficit(s) that may or may not be transient
  5. The TBI was followed within a maximum of 4 weeks by symptoms persisting for at least 6 months as of the Screening Visit in at least 3 of the following 6 categories listed in the ICD-10 criteria for Post-Concussive syndrome:

    • Headache, dizziness, malaise, fatigue, noise tolerance
    • Irritability, depression, anxiety, emotional lability
    • Subjective concentration, memory, or intellectual difficulties without neuropsychological evidence of marked impairment
    • Insomnia
    • Reduced alcohol tolerance
    • Preoccupation with above symptoms and fear of brain damage with hypochondriacal concern and adoption of sick role
  6. Rivermead Post-Concussion Questionnaire (RPQ-16) score ≥ 16

Exclusion Criteria

Participants will be excluded from study participation if one or more of the following exclusion criteria apply:

  1. History of open skull injury
  2. 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
  3. History of cerebrovascular accident
  4. History of cerebral aneurysm
  5. EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing, or ictal spikes, during the EEG recording
  6. Participation in any interventional research protocol within 3 months prior to the Screening Visit
  7. History of any type of ECT, MeRT, or rTMS
  8. Treated within 30 days of the Screening Visit with any antipsychotic medication
  9. Treated within 30 days of the Screening Visit with any anticonvulsant or anxiolytic medications listed as exclusionary in this protocol
  10. 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
  11. 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)
  12. 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
  13. 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
  14. An elevated risk of suicide or violence to others
  15. Current psychotherapeutic treatment, expected to continue throughout the trial, that was begun in the preceding 30 days at the time of the Screening Visit
  16. Current treatment with any prohibited concomitant medication (i.e., Gabapentin, Pregabalin, Topiramate) that has not been stable for the preceding 30 days at the time of the Screening Visit
  17. Inability to acquire a satisfactory EEG/ECG at Baseline, or on a routine basis
  18. Pregnant, or female unwilling to use effective birth control during the course of the trial
  19. Plan to move away from the area, or knowledge that there will be a deployment, prior to 9 weeks from the Screening Visit
  20. 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 would prevent the participant from completing the study

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
Contact: David Keyser, PhD 301-816-8461 david.keyser@usuhs.edu
Contact: Dmitry Mirochnitchenko 301-816-8462 dmitry.mirochnitchenko.ctr@usuhs.edu

Locations
United States, California
Naval Special Warfare Recruiting
San Diego, California, United States, 92103
Contact: Diana Lee    619-255-2112    dianamerts202@gmail.com   
Contact: Christa Cooper    619-255-2112    christa.merts201@gmail.com   
Principal Investigator: James Chung, DO         
United States, Florida
MacDill Air Force Base Recruiting
Macdill Air Force Base, Florida, United States, 33621
Contact: MaLisa Lewis    801-989-0656    malisa.lewis.ctr@us.af.mil   
Contact: Katryna Deary    813-831-9911    katryna.deary.ctr@socom.mil   
Principal Investigator: Scott Cota, MD         
Sponsors and Collaborators
Newport Brain Research Laboratory
Uniformed Services University of the Health Sciences
U.S. Special Operations Command
Henry M. Jackson Foundation for the Advancement of Military Medicine
KAI Research
Investigators
Principal Investigator: Scott Cota, MD SOCOM
Principal Investigator: James Chung, DO Naval Hospital Camp Pendleton

Publications:
ACRM: Mild Traumatic Brain Injury Committee. (1993). Definition of mild traumatic brain injury. J Head Trauma Rehabil, 8, 86-87.
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.
CONSORT Group. (2010). CONSORT 2010. Retrieved January 13, 2016, from CONSORT Transparent Reporting of Trials: http://www.consort-statement.org/consort-2010
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.
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
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.
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.
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
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.
World Health Organization, editors. (1993). The ICD-10 Classification of Mental and Behavioural Disorders Diagnostic Criteria for Research. Geneva: World Health Organization.

Responsible Party: Newport Brain Research Laboratory
ClinicalTrials.gov Identifier: NCT02990793     History of Changes
Other Study ID Numbers: MeRT-TBI-005
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Newport Brain Research Laboratory:
PTSD
Concussion
TBI
TMS

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Post-Traumatic
Post-Concussion Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating