MeRT for Post-Traumatic Stress Disorder

(MeRT-005-B Trial)

No longer recruiting at 8 trial locations

Overseen By Justin Winas, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wave Neuroscience

Must not be taking: Antipsychotics, Benzodiazepines, Anticonvulsants, others

Disqualifiers: Neurological disorders, Cerebrovascular accident, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Magnetic e-Resonance Therapy (MeRT) to determine its safety and effectiveness for people with Post-Traumatic Stress Disorder (PTSD). Participants will receive either the active MeRT treatment or a sham (placebo) version for comparison. It suits those diagnosed with PTSD who have experienced symptoms for at least six months. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.

Will I have to stop taking my current medications?

The trial requires that certain medications be stable for at least 60 days before the screening visit. If you are taking antipsychotic, benzodiazepine, or anticonvulsant medications, you must stop them at least 30 days before the screening visit. Please consult with the trial team for specific guidance on your medications.

What prior data suggests that MeRT treatment is safe for PTSD?

Research has shown that MeRT (Magnetic e-Resonance Therapy) uses gentle magnetic waves to help treat conditions like PTSD (Post-Traumatic Stress Disorder). This method resembles Transcranial Magnetic Stimulation (TMS), which the FDA has approved for treating depression and OCD (Obsessive Compulsive Disorder).

While researchers are testing MeRT specifically for PTSD, it builds on the safety record of TMS. Studies on TMS indicate it is generally well-tolerated, with some people experiencing mild side effects like headaches or dizziness. As MeRT is a type of TMS, it may have a similar safety profile. However, since MeRT is still under study for PTSD, more research is needed to confirm its safety for this specific use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for PTSD, which typically include therapy and medications like SSRIs, MeRT (Magnetic e-Resonance Therapy) uses a different approach. MeRT is unique because it combines transcranial magnetic stimulation (TMS) with EEG brain mapping to personalize treatment, aiming to directly target and adjust brain activity patterns associated with PTSD. Researchers are excited about this method because it might offer a more targeted, non-invasive alternative that could potentially lead to quicker and more effective relief for PTSD symptoms.

What evidence suggests that MeRT Treatment might be an effective treatment for PTSD?

Research has shown that Magnetic e-Resonance Therapy (MeRT) could help treat Post-Traumatic Stress Disorder (PTSD). In this trial, participants will receive either Active MeRT Treatment or Sham MeRT Treatment. Studies suggest that MeRT may improve brain wave patterns and reduce PTSD symptoms by adjusting brain activity. This therapy is non-invasive, meaning it doesn't require surgery or entering the body, making it a less intense treatment option. While more research is needed, early results are promising for people with PTSD. ^{1 2 5 6 7}

Who Is on the Research Team?

Kenneth Ramos, MD,PhD

Principal Investigator

Texas A&M University

Adele Gilpin, PhD,JD

Principal Investigator

GilpinPhillips BIOMED, LLC

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with PTSD, diagnosed per DSM-V criteria and a PCL-5 score of at least 30. Participants must have had symptoms for over six months. Exclusions include those with severe brain injuries, neurological disorders, recent participation in other trials, certain medication use, metal implants affected by magnets, significant medical conditions or substance abuse issues.

Inclusion Criteria

Minimum PCL-5 score of 30

I have had PTSD symptoms for at least 6 months.

Diagnosis of PTSD according to DSM-V criteria via CAPS-5

Exclusion Criteria

History of open skull injury

My traumatic event happened before I turned 16.

I have taken antipsychotic medication within the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either active or sham MeRT treatment for 5 weeks

5 weeks

Daily weekday visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person) at 3 weeks, 90 days, and 180 days post-treatment

Open-label extension

Participants who received sham treatment and continue to be eligible are offered up to 25 active MeRT treatments

What Are the Treatments Tested in This Trial?

Interventions

• MeRT Treatment

Trial Overview

The study tests the safety and effectiveness of Magnetic e-Resonance Therapy (MeRT) on individuals with PTSD after Traumatic Brain Injury (TBI). It compares active MeRT treatment to a sham (placebo-like) procedure to see if there's an improvement in PTSD symptoms.

How Is the Trial Designed?

Group I: Active MeRT Treatment Active Control 1 Intervention

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

Group II: Sham MeRT Treatment Placebo Group 1 Intervention

Sham treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 5 weeks.

Who Is Running the Clinical Trial?

Wave Neuroscience

Lead Sponsor

Trials

14

Recruited

1,000+

Peachtree BioResearch Solutions

Collaborator

Trials

2

Recruited

160+

Texas A&M University

Collaborator

Trials

156

Recruited

28,900+

Navitas Clinical Research, Inc

Collaborator

Trials

4

Recruited

2,300+

GilpinPhillips BIOMED, LLC

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

Cognitive processing therapy (CPT) has been shown to be an effective treatment for PTSD in active duty military personnel, as demonstrated in a case study of a service member who underwent 13 therapy sessions.

The case study highlights significant progress in reducing PTSD symptoms and achieving treatment goals, showcasing the practical application of CPT in an outpatient setting and addressing clinical challenges faced during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Study of Cognitive Processing Therapy for a Military Medic With Posttraumatic Stress Disorder. Wiley, RE.[2020]

Ketamine, an NMDA receptor antagonist, shows promising rapid antidepressant effects in PTSD, with evidence from various studies including case reports and randomized trials, indicating its potential as a treatment option for this challenging condition.

Despite the variability in clinical presentation and treatment approaches, ketamine demonstrates encouraging safety and efficacy signals, suggesting it could be a valuable off-label intervention for patients with chronic, refractory PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of ketamine for posttraumatic stress disorder: a review of clinical evidence. Ragnhildstveit, A., Roscoe, J., Bass, LC., et al.[2023]

Methoxetamine (MXE), a ketamine analogue, has a high affinity for the NMDA receptor and may alleviate PTSD symptoms, as suggested by a case report of a US veteran who used it for its calming effects.

This case highlights the need for increased awareness of designer drugs like MXE, which are not detected by standard drug tests, to better address addiction treatment in both military and civilian populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Being with a Buddha": A Case Report of Methoxetamine Use in a United States Veteran with PTSD. Striebel, JM., Nelson, EE., Kalapatapu, RK.[2020]

The study aims to reduce dropout rates from prolonged exposure therapy for PTSD by providing peer support during in vivo exposure homework, with 150 veterans participating in a randomized controlled trial.

The effectiveness of this peer support approach will be measured by comparing treatment completion rates and PTSD symptom reduction between two groups: one receiving direct peer support during homework and another receiving general weekly check-ins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support during in vivo exposure homework to reverse attrition from prolonged exposure therapy for posttraumatic stress disorder (PTSD): description of a randomized controlled trial. Hernandez-Tejada, MA., Muzzy, W., Price, M., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02990793

Clinical Trial to Evaluate the Safety and Efficacy of MeRT ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4727473/

Magnetic Resonance Therapy Improves Clinical ...

These open-label data show trends toward normalization of EEG and concomitant clinical improvement using magnetic stimulation for PTSD.

3.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT02990793/clinical-trial-to-evaluate-the-safety-and-efficacy-of-mert-treatment-in-post-traumatic-stress-disorder

Clinical Trial to Evaluate the Safety and Efficacy of MeRT ...

The purpose of this study is to evaluate the safety and efficacy of individualized, Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Post- ...

4.

braintreatmentmichigan.com

braintreatmentmichigan.com/ptsd-treatment/

PTSD Treatment with MeRT - Brain ...

'This study suggests that non-invasive neuromodulation magnetic resonance therapy may lead clinical improvements as well as a trend toward normalization of EEG ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11224515/

A retrospective chart review to assess the impact of alpha ...

Magnetic resonance therapy improves clinical phenotype and EEG alpha power in posttraumatic stress disorder. Trauma month. (2015) 20:e27360 ...

6.

mertptsdtrial.com

mertptsdtrial.com/

MeRT PTSD Trial

TMS has been cleared by the FDA for treatment-resistant Major Depressive Disorder, Obsessive Compulsive Disorder, and Nicotine Cessation. MeRT is now being used ...

7.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK566938/

Evidence Brief: Transcranial Magnetic Stimulation (TMS) for ...

The goal of this review is to synthesize important and recent evidence on TMS effectiveness and safety for treatment of chronic pain, PTSD, TBI, opioid ...