Clinical trial NCT02990793: Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Post-Traumatic Stress Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PostTraumatic Stress Disorder
Traumatic Brain Injury
Postconcussive Symptoms
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
Lead sponsor: Wave Neuroscience
Sponsor class: INDUSTRY
Collaborators: name: Texas A&M University
name: GilpinPhillips BIOMED, LLC
name: Peachtree BioResearch Solutions
First posted: 2016-12-13
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Change in PTSD Symptoms
timeFrame: Five weeks
Secondary outcomes:
Other outcomes:
measure: Safety Outcomes - Incidents and types of adverse events
timeFrame: Approximately 3 months
Locations:
city: Costa Mesa
country: United States
facility: BrainHealth Solutions
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: San Diego
country: United States
facility: SoCal Neuroscience Research Unit
state: California
city: Raleigh
country: United States
facility: UNC Rex Hospital
state: North Carolina
city: Columbus
country: United States
facility: Columbus Brain Research Center
state: Ohio
city: Bryn Mawr
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Plano
country: United States
facility: Texas A&M Research Center
state: Texas
city: Bellevue
country: United States
facility: Seattle Neuropsychiatric Treatment Center (Seattle NTC)
state: Washington
Study officials:
affiliation: Texas A&M University
name: Kenneth Ramos, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: GilpinPhillips BIOMED, LLC
name: Adele Gilpin, PhD,JD
role: STUDY_CHAIR
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