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

Traumatic Brain Injury Clinical Trial

— MeRT-005-B  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02990793
• Other study ID #: MeRT-005-B
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Wave Neuroscience
• Contact: Adele Gilpin, PhD,JD
• Phone: 949-229-2869
• Email: mert005b[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Post-Concussion Syndrome
• Postconcussive Symptoms
• PostTraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury

Intervention

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.
• Sham MeRT Treatment
rTMS coil does not emit magnetic stimulation.

Locations

Country	Name	City	State
United States	Seattle Neuropsychiatric Treatment Center (Seattle NTC)	Bellevue	Washington
United States	Center for Interventional Pain and Spine	Bryn Mawr	Pennsylvania
United States	Columbus Brain Research Center	Columbus	Ohio
United States	BrainHealth Solutions	Costa Mesa	California
United States	Texas A&M Research Center	Plano	Texas
United States	SoCal Neuroscience Research Unit	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
Wave Neuroscience	GilpinPhillips BIOMED, LLC, Peachtree BioResearch Solutions, Texas A&M University

Country where clinical trial is conducted

United States, 

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* Note: There are 171 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcomes - Incidents and types of adverse events	Number and type of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Approximately 6 months
Primary	Change in PTSD Symptoms	Change in PTSD symptoms as measured by the PTSD Checklist-5 (PCL-5).	Five weeks