MeRT for Post-Traumatic Stress Disorder

(MeRT-005-B Trial)

Recruiting at 7 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

152 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called MeRT, which uses magnets to help people with PTSD by improving their brain function.

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.

Is MeRT treatment safe for humans?

There is no specific safety data available for MeRT treatment in the provided research articles. ^{1 2 3 4 5}

How is MeRT treatment different from other treatments for PTSD?

MeRT (Magnetic e-Resonance Therapy) is unique because it uses magnetic fields to stimulate specific areas of the brain, potentially offering a novel approach compared to traditional PTSD treatments like prolonged exposure therapy or cognitive processing therapy, which focus on psychological techniques. ^{6 7 8 9 10}

Research Team

Kenneth Ramos, MD,PhD

Principal Investigator

Texas A&M University

Adele Gilpin, PhD,JD

Principal Investigator

GilpinPhillips BIOMED, LLC

Eligibility Criteria

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

My traumatic event happened before I turned 16.

History of open skull injury

I have taken antipsychotic medication within the last 30 days.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of mirtazapine in patients with post-traumatic stress disorder in Korea: a pilot study. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

"Being with a Buddha": A Case Report of Methoxetamine Use in a United States Veteran with PTSD. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of posttraumatic stress disorder: the impact of paroxetine. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The potential of ketamine for posttraumatic stress disorder: a review of clinical evidence. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Do older veterans experience change in posttraumatic cognitions following treatment for posttraumatic stress disorder? [2023]

7. England 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Evaluating the effect of electroconvulsive therapy (ECT) on post-traumatic stress disorder (PTSD): A systematic review and meta-analysis of five studies. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Massed versus standard prolonged exposure for posttraumatic stress disorder in Australian military and veteran populations (RESTORE trial): Study protocol for a non-inferiority randomized controlled trial. [2022]