MRI-Guided TMS for Post-Traumatic Stress Disorder

ET
DM
Overseen ByDaniel M Stout, PhD
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 method to treat PTSD (post-traumatic stress disorder) in Veterans using MRI-guided TMS (transcranial magnetic stimulation). TMS is a noninvasive treatment that uses magnetic pulses to alter brain activity. The study examines whether MRI-guided intermittent theta burst stimulation (iTBS) can ease PTSD symptoms by targeting specific brain areas linked to stress. Veterans with PTSD who can commit to 20 treatment sessions over a few weeks might be suitable candidates for the trial.

As an unphased trial, this study offers Veterans the chance to contribute to groundbreaking research that could lead to new PTSD treatments.

What prior data suggests that MRI-guided TMS is safe for treating PTSD?

Research has shown that MRI-guided intermittent theta burst stimulation (iTBS) is generally safe for treating PTSD. Past studies have found iTBS to be well-tolerated, with no serious safety issues reported. This treatment uses magnetic pulses to target specific brain areas without requiring surgery.

One study found that iTBS is as safe as other brain stimulation treatments, such as high-frequency stimulation. Another study demonstrated that TMS, which includes iTBS, usually does not cause serious side effects for PTSD patients.

Most patients tolerate the treatment well, experiencing promising rates of symptom relief for PTSD. While some may not see immediate improvement, the overall safety remains reassuring. This makes iTBS a potential option for those considering new PTSD treatments.12345

Why are researchers excited about this trial?

Unlike standard treatments for PTSD, which often involve medication or talk therapy, MRI-guided intermittent theta burst stimulation (iTBS) offers a new approach by using targeted brain stimulation. Researchers are excited about this method because it uses MRI to precisely guide the stimulation to specific brain areas, potentially enhancing its effectiveness. Additionally, iTBS may work faster than traditional treatments, which can take weeks or months to show results, providing quicker relief for those suffering from PTSD.

What evidence suggests that MRI-guided TMS is effective for PTSD?

Research has shown that MRI-guided intermittent theta burst stimulation (iTBS) can help reduce symptoms of post-traumatic stress disorder (PTSD). For example, in a study with 50 veterans, many experienced significant improvements in their social and work lives after receiving iTBS. Another study found that iTBS can quickly and effectively lower PTSD symptoms, with many participants feeling much less distress. While other treatments like repetitive transcranial magnetic stimulation (rTMS) might sometimes work better, iTBS has proven its worth without causing major side effects. In this trial, participants will receive either active iTBS or a sham version to further evaluate its effectiveness. Overall, iTBS is a promising noninvasive option for managing PTSD symptoms.26789

Who Is on the Research Team?

DM

Daniel M Stout, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for Veterans diagnosed with PTSD. Participants should be able to undergo MRI scans and attend multiple treatment sessions. People with certain medical or psychiatric conditions, metal implants, or other factors that make TMS or MRI unsafe cannot join.

Inclusion Criteria

Willing and able to complete magnetic resonance imaging (MRI) assessments before and after the iTBS treatment course
Veteran status
Able to provide informed consent
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Exclusion Criteria

I have a neurological disorder that affects my memory or thinking.
History of traumatic brain injury associated with an estimated loss of consciousness greater than 30 minutes
Current acute suicidal ideation or recent psychiatric hospitalization when, in the judgment of the study clinician or treating psychiatrist, the condition would interfere with safe study participation
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 20 sessions of active or sham intermittent theta burst stimulation (iTBS) over 4 to 6 weeks

4-6 weeks
20 visits (in-person)

Follow-up

Participants are monitored for changes in PTSD symptoms and neural measures post-treatment

8 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • MRI-Guided intermittent theta burst stimulation (iTBS)

Trial Overview

The study tests whether personalized brain stimulation (MRI-guided iTBS, a type of TMS) can reduce PTSD symptoms in Veterans compared to a non-active (sham) version. Participants are randomly assigned to either the active or sham group over 20 sessions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active MRI-Guided intermittent theta burst stimulation (iTBS)Experimental Treatment1 Intervention
Group II: Sham MRI-Guided intermittent theta burst stimulation (iTBS)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

TMS for Post-Traumatic Stress Disorder · Info for Participants

A study involving 50 veterans with PTSD showed that intermittent theta-burst stimulation (iTBS) significantly improved social and occupational functioning ...

Theta Burst Stimulation Is Not Inferior to High-Frequency ...

However, a similar study found that 5 hz rTMS was superior to iTBS in patients with PTSD and co-morbid MDD, resulting in a greater reduction in ...

Comparing the Efficacy of fMRI-Guided vs. Standard iTBS ...

The main outcome of this trial is response rate as determined by ≥ 50% reduction in Grid HRSD-17 scores. Secondary outcomes include remission ...

Target engagement during interleaved iTBS-fMRI predicts ...

Results Accelerated iTBS was associated with rapid, sustained symptom reductions (ΔHAM-D17 −9.01, p<0.001); overall response and remission ...

MRI-guided brain stimulation improves PTSD recovery in ...

At one month post-treatment, 85% of active TMS recipients had achieved clinically significant reductions in PTSD symptoms, compared with 59% of ...

Comparing the Efficacy of fMRI-Guided vs. Standard iTBS ...

The main outcome of this trial is response rate. Secondary outcomes include remission rate, change in depression, anxiety and anhedonia ...