Personalized Brain Stimulation for Post-Traumatic Stress Disorder

AB
JB
Overseen ByJoseph Bonvie, PsyD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new personalized brain stimulation treatment for military service members and veterans with PTSD. The goal is to determine if a tailored brainwave test (EEG) can guide therapy to provide better relief for PTSD symptoms than standard methods. Participants will receive either the personalized brain stimulation, known as Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS), or a placebo-like treatment over six weeks. Researchers will monitor changes in mood, sleep, and overall well-being. Military service members diagnosed with PTSD might be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for PTSD.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use antipsychotic or anticonvulsant medications. If you have started a new PTSD-specific treatment in the past 4 weeks, you may not be eligible unless your regimen is stable.

What prior data suggests that this personalized brain stimulation is safe for treating PTSD?

A previous study showed that personalized repetitive transcranial magnetic stimulation (PrTMS) is generally safe for people with PTSD. This treatment uses magnetic fields to stimulate the brain and has FDA approval for treating depression, indicating it is usually well-tolerated. Studies have found that side effects are typically mild, with some people experiencing headaches. Although more research is needed, early findings suggest that PrTMS could be a promising treatment with a good safety profile.12345

Why are researchers excited about this trial?

Researchers are excited about Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for PTSD because it offers a tailored approach to brain stimulation. Unlike standard treatments like medication and traditional therapy, PrTMS uses EEG-guided technology to customize stimulation parameters for each patient, adjusting them over time based on ongoing neurocognitive assessments. This personalized method aims to enhance effectiveness and reduce side effects, potentially offering faster relief compared to conventional methods.

What evidence suggests that this personalized brain stimulation is effective for PTSD?

Research has shown that personalized repetitive transcranial magnetic stimulation (PrTMS) can help treat PTSD in veterans. One study found that participants experienced a significant reduction in PTSD symptoms, with an average drop of 23 points on a scale measuring PTSD severity. About two-thirds of the patients reported improvement after 4 to 6 weeks of treatment. This trial will compare two groups: one receiving active PrTMS, which uses brainwave tests (EEG) to customize therapy for each person, and another receiving sham PrTMS, which mimics the sound and sensation of active treatment without delivering a therapeutic magnetic field. These early findings suggest that PrTMS might help reduce PTSD symptoms and improve overall well-being.12367

Who Is on the Research Team?

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Sofia E Matta, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults who are current or former military members with a confirmed diagnosis of PTSD and significant symptoms. Participants must speak English, be stable on any PTSD treatment, and not have certain brain injuries, seizure disorders, metal implants in the head, recent rTMS therapy, or unstable medical conditions.

Inclusion Criteria

Age 18 years or older
Reserve or former member of the military (veteran status)
Proficient in English (spoken and written) to ensure understanding of study procedures and informed consent
See 2 more

Exclusion Criteria

History of open-skull traumatic brain injury
I have had serious seizures or manic episodes.
I started PTSD treatment within the last 4 weeks or am on a stable treatment plan.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized, EEG-guided repetitive transcranial magnetic stimulation (PrTMS) or sham treatment administered 5 days per week for 6 weeks

6 weeks
30 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments over 6 months

6 months
3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)

Trial Overview

The study tests a personalized brain stimulation treatment (PrTMS) tailored by EEG for PTSD. Participants are randomly assigned to receive either real PrTMS or a sham (inactive) version over 6 weeks. The effects on PTSD symptoms, mood, sleep, and well-being will be measured.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active PrTMS (EEG-Guided rTMS)Active Control1 Intervention
Group II: Sham PrTMSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

United States Air Force Research Laboratory

Collaborator

Trials
3
Recruited
310+

Citations

Personalized repetitive transcranial magnetic stimulation ...

We pursued the treatment of combat veterans with PTSD (n = 185) using an expanded form of repetitive transcranial magnetic stimulation (rTMS) termed ...

Personalized Repetitive Transcranial Magnetic Stimulation ...

The goal is to see whether this personalized approach can provide greater and longer-lasting relief for individuals living with PTSD. Detailed ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37609394/

Personalized repetitive transcranial magnetic stimulation ...

Following 4 - 6 weeks of PrTMS® therapy in addition to routine PTSD therapy, veterans exhibited significant clinical improvement accompanied by ...

EEG Guided Personalized rTMS (PrTMS®) for Post Traumatic ...

The results showed a substantial, mean reduction in PCL-5 score of 23 points, and diminished PTSD symptoms, in two-thirds of patients. Importantly, in addition ...

Personalized Repetitive Transcranial Magnetic Stimulation ...

This study is testing a personalized form of brain stimulation called PrTMS as a treatment for post-traumatic stress disorder (PTSD) in ...

A Meta-Analysis Based on Randomized Controlled Trials

One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder. Neuropsychopharmacology. 2020;45(6):940–946. doi:10.1038 ...

Accelerated Transcranial Magnetic Stimulation for Post- ...

The study checks if this approach is practical, safe (tracking side effects like headaches), and shows early signs of reducing PTSD symptoms ( ...