15 Participants NeededMy employer runs this trial

Transcranial Magnetic Stimulation for PTSD

LG
MA
Overseen ByMark Allen, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cognitive FX
Must be taking: Psychotropic medications
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 brain stimulation treatment called transcranial magnetic stimulation (TMS) for individuals with post-traumatic stress disorder (PTSD). The researchers aim to determine if this safe, non-invasive method can reduce PTSD symptoms, such as flashbacks and mood changes, by enhancing the brain's control over fear. Participants will receive personalized treatment based on their brain scans over five days, with follow-ups for three months to monitor any changes. Ideal candidates are adults who have experienced PTSD for over three months and can attend daily sessions for five days. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for PTSD.

Do I need to stop my current medications for the trial?

If you're taking psychotropic medications, you need to be on a stable dose for at least 6 weeks before joining the study and can't change it during the trial.

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

Research has shown that accelerated transcranial magnetic stimulation (TMS) is generally safe and well-tolerated. This treatment uses magnetic fields to influence brain activity without surgery. Studies have found that most people tolerate it well, though some may experience mild side effects like headaches.

Previous research on TMS for PTSD showed promising results, with significant reductions in PTSD symptoms. While the FDA has approved TMS for treating depression, it is still under study for PTSD. This offers reassurance about its safety, as it has been tested for another condition.

Overall, current evidence considers accelerated TMS a relatively safe option.12345

Why are researchers excited about this trial?

Most treatments for PTSD, like therapy and medication, can take weeks or months to show results. However, accelerated Transcranial Magnetic Stimulation (TMS) has the potential to show improvements much faster, sometimes within just a few days. This treatment is exciting because it targets the brain directly using magnetic pulses, specifically on the right dorsolateral prefrontal cortex, which is thought to play a role in PTSD symptoms. Researchers are hopeful that this method could offer a quick and effective alternative for those who haven't found relief from traditional options.

What evidence suggests that accelerated transcranial magnetic stimulation might be an effective treatment for PTSD?

Research has shown that transcranial magnetic stimulation (TMS) can help reduce PTSD symptoms. In one study, 85% of participants who received TMS reported significant improvement within a month. Other research supports TMS as generally effective for reducing PTSD symptoms over time. In this trial, all participants will receive accelerated TMS, a faster version that offers more scheduling options. Although some studies have shown mixed results, many patients have experienced significant improvements quickly. Overall, TMS is considered a safe and promising treatment for PTSD.13567

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with moderate or worse PTSD symptoms lasting at least 3 months. Participants must be able to have MRI scans, attend daily sessions for a week, and not have certain medical or psychiatric conditions (like seizures, psychosis, recent hospitalization), metal implants in the head, or unstable health.

Inclusion Criteria

I can attend treatment every day for five weekdays in a row.
Eligible for 1.5T MRI scanning (no contraindications)
I am between 18 and 65 years old.
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Exclusion Criteria

TMS Contraindications: History of significant head trauma with loss of consciousness >10 minutes
Psychiatric Exclusions: Lifetime history of psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder)
Psychiatric Exclusions: Psychiatric hospitalization within past 3 months
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline fMRI

Baseline fMRI for targeting the right dorsolateral prefrontal cortex

1 day
1 visit (in-person)

Treatment

Participants receive accelerated cTBS treatment over 5 consecutive days

5 days
10 sessions per day (in-person)

Post-treatment Assessment

Post-treatment assessments within 48-72 hours after treatment completion

2-3 days
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
2 visits (in-person) at 1 and 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Accelerated Transcranial Magnetic Stimulation

Trial Overview

The study tests a personalized brain stimulation treatment called accelerated TMS guided by each person's brain scan. Over five days, participants receive multiple short sessions targeting specific brain areas linked to fear and control to see if this approach is safe and can quickly reduce PTSD symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Active accelerated TMS stimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cognitive FX

Lead Sponsor

Citations

Pragmatic Accelerated Transcranial Magnetic Stimulation for ...

Limitations aside, this report describes large and robust improvements in PTSD symptoms in a short period of time using a highly scalable TMS ...

Effectiveness of transcranial magnetic stimulation for ...

Currently, meta-analyses of TMS for PTSD outnumber novel RCT publications and indicate that TMS is generally effective at PTSD symptom reduction over time, with ...

Residential Therapy With Navigated Transcranial Magnetic ...

Clinically significant reductions in PTSD symptoms were achieved by 85% of active TMS vs 59% of sham recipients at 1-month follow-up. Meaning ...

Transcranial Magnetic Stimulation for Post-traumatic Stress ...

Studies have been done to assess the overall efficacy of TMS. However, results have been conflicting, and sample sizes were small. More research should be done ...

A new add-on for combat PTSD treatment: MRI-guided ...

One month after treatment completion, 85% of those in the active TMS group showed significant symptom relief, both self-reported and clinically, ...

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 ( ...

Targeted Accelerated TMS for Post-Traumatic Stress ...

Transcranial magnetic stimulation (TMS) is a focal, non-invasive form of brain stimulation that has FDA clearance for depression. In this study, a form of TMS ...