What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

The most common side effects of transcranial magnetic stimulation (TMS) and repetitive transcranial magnetic stimulation (rTMS) include mild to moderate headaches, scalp discomfort at the site of stimulation, and tingling or spasms in facial muscles. Some patients may experience lightheadedness. Serious side effects are rare but can include seizures, particularly in individuals with a history of epilepsy. Overall, these treatments are considered safe with a low incidence of severe adverse events.

What prior FDA approvals exist?

The FDA has approved transcranial magnetic stimulation (TMS) for various neurological and psychiatric conditions, including major depressive disorder and migraine. TMS involves using magnetic fields to stimulate nerve cells in the brain, which is similar to the concept of Biometrics-guided Magnetic e-Resonance Therapy (MeRT). While specific FDA approvals for the treatment of Post-Concussion Syndrome (PCS) using neuromodulation techniques like MeRT are not detailed, the approval of TMS for other conditions suggests a potential for similar approaches to be explored for PCS.

What other types of research exist?

Promising novel alternatives to Biometrics-guided Magnetic e-Resonance Therapy (MeRT) for Post-Concussion Syndrome patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing headache days and improving functional outcomes in various conditions. 2) Transcranial Direct Current Stimulation (tDCS), which has been explored for enhancing neurocognition and mood regulation. 3) Vagus Nerve Stimulation (VNS), which has demonstrated benefits in treatment-resistant depression and may offer potential for PCS management.

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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

Summary

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

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in PTSD Symptoms

Secondary study objectives

Change in PPCS

Other study objectives

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.

0 / 4Eligibility criteria met

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.