Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

(RAPID5 Trial)

Not yet recruiting at 1 trial location

Overseen By Michelle R Madore, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic disorder, Bipolar I, Substance use, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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 tests a new, quicker method of using transcranial magnetic stimulation (TMS), a non-invasive brain treatment, to assist veterans with post-traumatic stress disorder (PTSD). The goal is to determine if a 5-day intensive TMS schedule, called the Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days, can effectively reduce PTSD symptoms compared to a placebo. Suitable candidates have experienced PTSD for an extended period and continue to have symptoms despite ongoing treatment. Participants must be comfortable undergoing an MRI and should not have certain medical implants or conditions that could interfere with the treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for PTSD.

Will I have to stop taking my current medications?

No, you can continue taking your current medications as long as they have been stable for at least 6 weeks before the study starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe for treating post-traumatic stress disorder (PTSD). TMS uses magnetic fields to stimulate brain cells. Previous studies have shown promising results, with few side effects reported. Many patients handled the treatment well. One study found that using TMS at a frequency of 10 Hz improved PTSD symptoms like anxiety, without serious problems. The FDA has also approved TMS for treating depression, helping people quit smoking, and managing obsessive-compulsive disorder, suggesting its safety for other uses as well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Researchers are excited about the use of Transcranial Magnetic Stimulation (TMS) for treating PTSD because it offers a rapid and non-invasive therapy option that could deliver results in just five days. Unlike typical PTSD treatments that often rely on medications like SSRIs or prolonged therapy sessions, TMS targets specific brain areas by using magnetic fields to stimulate nerve cells. This novel method has the potential to provide quicker relief from symptoms without the systemic side effects associated with medication. Furthermore, the use of a sham TMS arm in the trial helps differentiate the actual impact of active TMS, ensuring a more accurate assessment of its effectiveness.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that transcranial magnetic stimulation (TMS) could help treat PTSD. Studies have found that targeting certain brain areas with TMS effectively reduces PTSD symptoms. Many patients find TMS both helpful and easy to handle. This treatment already has approval for depression and OCD, supporting its safety and effectiveness. In this trial, participants will join either an active TMS group or a sham TMS group. Early results suggest that a faster version of TMS, administered over five days, might provide quicker relief for PTSD symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Michelle R Madore, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

This trial is for veterans with PTSD who are seeking an alternative treatment. Participants should be available for a rapid 5-day intervention and willing to undergo either real or sham transcranial magnetic stimulation (TMS). Specific eligibility criteria details were not provided.

Inclusion Criteria

I still have symptoms despite treatment for over 6 weeks.

I can see and hear well enough for brain function tests.

I am willing to join a clinical trial for 4 to 6 months.

Exclusion Criteria

Acute illness or unstable chronic illness

Inability to read, unable to verbalize understanding, and voluntarily sign the Informed Consent

Primary psychotic disorder, bipolar I disorder, and greater than moderate substance use disorder within the last month (excluding nicotine/caffeine)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive five TMS treatments per day for five consecutive business days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days

Trial Overview The study is testing the effectiveness of an accelerated, intensive form of TMS over just five days compared to a sham (placebo-like) procedure. The goal is to see if this quick approach can reduce PTSD symptoms effectively and lastingly.

How Is the Trial Designed?

Group I: Active TMS Active Control 1 Intervention

Active transcranial magnetic stimulation

Group II: Sham TMS Placebo Group 1 Intervention

Non-active/sham transcranial magnetic stimulation

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24486424/

Review of the effectiveness of transcranial magnetic ... Conclusions: TMS for PTSD appears to be an effective and well-tolerated treatment that warrants additional study to further define treatment parameters, course, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X1930261X

Synchronized transcranial magnetic stimulation for ... These results support the feasibility, tolerability and potential efficacy of sTMS for comorbid PTSD and MDD.

4. nature.com nature.com/articles/s41398-020-0851-5

Non-invasive brain stimulation for posttraumatic stress ... Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) hold promise for the treatment of posttraumatic stress ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8558793/

Transcranial magnetic stimulation for post-traumatic stress ... Compared with sham and 1 Hz TMS, 10 Hz TMS showed improvement in core PTSD symptoms of re-experiencing and avoiding as well as anxiety, with no ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06081309

NCT06081309 | EEG Personalized Transcranial Magnetic ... This is an open-label safety pilot study of the Electroencephalogram (EEG) Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress ...