Accelerated TMS for PTSD

(TAP Trial)

Overseen By Interventional Psychiatry Research Group

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Pregnancy, No new medications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called accelerated TMS (aTMS) for people with PTSD, particularly those in the military. aTMS is a faster version of a brain stimulation treatment that has shown promise for depression and is now being explored for PTSD to see if it offers quick relief. Participants will receive either the active treatment targeting a specific brain circuit or a sham (fake) version to compare results. Suitable candidates are those with moderate PTSD symptoms, diagnosed according to specific guidelines, who can maintain their daily routines and treatments consistently during the study. As an unphased trial, this study provides an opportunity to explore a potentially groundbreaking treatment for PTSD.

Will I have to stop taking my current medications?

The trial requires that you do not start any new medications or increase your current medication doses before, during, or after the treatment. You can continue taking your current medications as long as there are no changes.

What prior data suggests that accelerated TMS is safe for PTSD?

Research has shown that transcranial magnetic stimulation (TMS) is a safe treatment for conditions like depression. Most people find TMS manageable, experiencing only mild and temporary side effects such as headaches or scalp discomfort. Accelerated TMS (aTMS) is a newer method that speeds up treatment by offering more sessions in a shorter time. Studies suggest that aTMS is not only effective but also safe, providing more flexible scheduling, which could benefit military personnel.

No major safety issues have been found with aTMS so far. Since TMS is already approved for treating depression, this approval provides some confidence in its safety. However, because aTMS is being tested for PTSD, it is important to remember that this specific use is still under study. These findings can help prospective trial participants understand what to expect in terms of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Accelerated TMS for PTSD is unique because it offers a faster approach to symptom relief compared to traditional therapies like prolonged exposure therapy or medication. This technique uses transcranial magnetic stimulation (TMS) to target specific brain regions involved in PTSD with precision, thanks to the use of neuronavigation and individualized resting state functional connectivity. Unlike standard treatments that may take weeks or months to take effect, accelerated TMS has the potential to deliver noticeable improvements in a much shorter time frame, which is a game-changer for those seeking rapid relief from PTSD symptoms. Researchers are excited about the possibility of providing a non-invasive, efficient, and personalized treatment option for individuals struggling with PTSD.

What evidence suggests that accelerated TMS might be an effective treatment for PTSD?

Research shows that accelerated transcranial magnetic stimulation (aTMS) holds promise for treating PTSD. Studies have found that TMS, especially when applied to specific brain areas, can alleviate PTSD symptoms. Traditional TMS has successfully treated depression, with many individuals responding well. Accelerated TMS works faster and offers more flexibility, which benefits military personnel. Early research on similar treatments suggests that aTMS can significantly improve mood within days. In this trial, participants will receive either active aiTBS or sham aiTBS, both using neuronavigation to a treatment target identified with individualized resting state functional connectivity. Although aTMS has primarily been tested for depression, it is now being studied for PTSD using a new brain target, offering hope for quicker relief. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for veterans and active-duty military personnel with PTSD. Participants should be those who haven't found relief through conventional treatments like therapy or medication, and are looking for a rapid intervention that fits into a short medical leave.

Inclusion Criteria

English proficiency sufficient to understand risks/benefits

I am between 18 and 65 years old.

I have moderate to severe PTSD symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated TMS (aTMS) treatment, involving 10 imaging-guided treatments per day for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments conducted at 1 week and 1 month post-treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated TMS

Trial Overview The study tests an accelerated form of Transcranial Magnetic Stimulation (aTMS), which targets specific brain circuits related to PTSD. It's given as 10 treatments per day over 5 days, aiming to quickly reduce symptoms in participants.

How Is the Trial Designed?

Group I: Active aiTBS Active Control 1 Intervention

Participants in this group will receive active aiTBS with neuronavigation to a treatment target identified with individualized resting state functional connectivity.

Group II: Sham aiTBS Placebo Group 1 Intervention

Participants in this group will receive sham aiTBS with neuronavigation to a treatment target identified with individualized resting state functional connectivity.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Mass General Home Base Program

Collaborator

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X2500378X

Effectiveness of Transcranial Magnetic Stimulation for ... Effectiveness of Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder: A Multisite, Propensity-Matched Cohort Study of Treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9193572/

Transcranial Magnetic Stimulation for Post-traumatic Stress ... Regardless of laterality, TMS application to the DLPFC seems to produce the most effective results in treatment of PTSD. Effectiveness of TMS therapy is ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07245641

Targeted Accelerated TMS for Post-Traumatic Stress ... This approach captures individual variability in response trajectory and aligns with our own data from aTMS treatment of TRD. The strength of ...

4. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(25)00111-1/fulltext

Pragmatic accelerated transcranial magnetic stimulation for ... Thus, extant work suggests that accelerated TMS is safe, effective, and offers greater scheduling flexibility. Within this context, TMS holds promise for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8581062/

Transcranial Magnetic Stimulation for Posttraumatic Stress ... Data from prior controlled trials of iTBS, with increased stimulation exposure, have appeared to provide comparable clinical outcomes compared with 5 Hz TMS.

6. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2019.18101160

Theta-Burst Transcranial Magnetic Stimulation for ... iTBS appears to be a promising new treatment for PTSD. Most clinical improvements from stimulation occurred early, which suggests a need for further ...