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

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)

Sponsors

Lead Sponsor: Wave Neuroscience

Collaborator: Uniformed Services University of the Health Sciences
U.S. Special Operations Command
Henry M. Jackson Foundation for the Advancement of Military Medicine
KAI Research

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

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 152 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).

A Pilot Phase I has completed in which 74 participants were recruited. Phase I will only be used for confirming the safety of MeRT for this indication. For the Test Phase II, 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.

Overall Status Suspended
Start Date July 24, 2017
Completion Date January 2021
Primary Completion Date January 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction in PPCS Four weeks
Secondary Outcome
Measure Time Frame
PTSD Symptom Reduction Four weeks
Enrollment 150
Condition
Intervention

Intervention Type: Device

Intervention Name: Active MeRT Treatment

Description: 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.

Arm Group Label: Active MeRT Treatment

Other Name: rTMS Active Stimulator

Intervention Type: Device

Intervention Name: Sham MeRT Treatment

Description: A personalized biometrics-guided protocol similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation.

Arm Group Label: Sham MeRT Treatment

Other Name: rTMS Sham Stimulator

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Naval Special Warfare
Location Countries

United States

Verification Date

November 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Active MeRT Treatment

Type: Active Comparator

Description: Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 4 weeks.

Label: Sham MeRT Treatment

Type: Sham Comparator

Description: 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.

Acronym MeRT-TBI-005
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov