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MeRT for Post-Traumatic Stress Disorder (MeRT-005-B Trial)

N/A
Recruiting
Led By James Chung, DO
Research Sponsored by Wave Neuroscience
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 - 65 years
Be older than 18 years old
Must not have
Index trauma occurred before the age of 16 years
History of any type of ECT, rTMS, or MeRT treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 months
Awards & highlights

Summary

This trial will test whether Biometrics-guided Magnetic e-Resonance Therapy is a safe and effective treatment for PTSD and PPCS following TBI.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort at the treatment site, headaches or dizziness due to magnetic stimulation. More serious risks could involve seizures or changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My traumatic event happened before I turned 16.
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I have had ECT, rTMS, or MeRT treatment before.
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I have a history of neurological disorders or conditions affecting my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in PTSD Symptoms
Secondary outcome measures
Change in PPCS
Other outcome measures
Safety Outcomes - Incidents and types of adverse events

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active MeRT TreatmentActive Control1 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 TreatmentPlacebo Group1 Intervention
Sham treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 5 weeks.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neuromodulation treatments for Post-Concussion Syndrome (PCS), such as Transcranial Magnetic Stimulation (TMS) and MeRT, work by using magnetic fields to modulate brain activity. TMS involves delivering magnetic pulses to specific brain regions to alter neuronal activity, which can help alleviate symptoms like headaches, mood disturbances, and cognitive deficits. MeRT tailors these magnetic pulses based on individual biomarkers, potentially offering a more personalized and effective treatment. These therapies are significant for PCS patients as they target the underlying neural dysfunctions, providing relief from persistent symptoms that are often resistant to conventional treatments.
Quantitative Susceptibility Mapping after Sports-Related Concussion.

Find a Location

Who is running the clinical trial?

Peachtree BioResearch SolutionsUNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
Wave NeuroscienceLead Sponsor
12 Previous Clinical Trials
764 Total Patients Enrolled
Texas A&M UniversityOTHER
141 Previous Clinical Trials
24,311 Total Patients Enrolled
~47 spots leftby Jul 2025