TMS for Post-Traumatic Stress Disorder

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must not be taking: Benzodiazepines

Disqualifiers: Seizures, Psychotic disorders, Substance abuse, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called transcranial magnetic stimulation (TMS) to determine its effectiveness for veterans with PTSD who haven't improved after one week of intensive outpatient therapy. The study compares real TMS to a sham version to assess its impact during the second week of therapy. Veterans who have participated in an intensive PTSD program for a week without symptom relief might be suitable candidates.

As an unphased trial, this study provides veterans an opportunity to explore new treatment options that might improve their symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that individuals on Benzodiazepine at a dose higher than 3mg or Lorazepam or equivalent are excluded. It might be best to discuss your specific medications with the trial coordinators.

What prior data suggests that this technique is safe for treating PTSD?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe. The FDA has approved it for treating depression, indicating a strong safety record. While researchers are exploring TMS for other conditions like PTSD (post-traumatic stress disorder), the focus here is on its safety.

Some studies suggest that TMS may not significantly reduce PTSD symptoms compared to a placebo treatment. However, these studies have not reported major safety issues. This suggests that while its effectiveness for PTSD is still under investigation, TMS is usually well-tolerated by patients.

Therefore, those considering TMS for PTSD can feel reassured about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TMS (Transcranial Magnetic Stimulation) for Post-Traumatic Stress Disorder (PTSD) because it offers a non-invasive approach that directly targets the brain. Unlike traditional treatments such as talk therapy and medications like SSRIs, TMS uses magnetic fields to stimulate nerve cells in the brain, which can be particularly beneficial for those who haven't found relief with other methods. This technique is promising because it may provide faster results with fewer side effects compared to medications, offering hope for individuals struggling with PTSD.

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

Research has shown that Transcranial Magnetic Stimulation (TMS) can help treat PTSD. A review of several studies found that TMS improved mood in people with PTSD. While TMS offers potential benefits, further research is needed to fully understand its effects on PTSD symptoms. In this trial, participants will join either an Active TMS arm or a Sham arm to evaluate TMS's effectiveness. Specifically, a type of TMS called theta burst stimulation showed positive results over a year in PTSD cases. Overall, TMS appears promising for those dealing with PTSD. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for veterans enrolled in a 2-week intensive outpatient program for PTSD who haven't seen symptom improvement in the first week. Specific eligibility details are not provided, but typically participants must meet certain health and condition-specific criteria.

Inclusion Criteria

Participants with an HDRS-21 score ≤ 26 at screening visit

I am a veteran aged 18-65 with stable PTSD symptoms during the first week of an intensive outpatient program.

Exclusion Criteria

Individuals with a history of substance abuse within the past six months

Individuals with a history of seizures or epilepsy (except those induced by ECT)

Individuals diagnosed with major, chronic mental health illnesses (e.g., Psychotic Disorders, Bipolar Disorders, Obsessive Compulsive Disorder)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intensive Outpatient Program (IOP) - Week 1

Participants undergo the first week of the intensive PTSD treatment program

1 week

Daily visits (in-person)

Intensive Outpatient Program (IOP) - Week 2 with iTBS or Sham

Participants receive either iTBS or sham treatment in addition to the standard IOP for PTSD

1 week

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1-month and 3-month follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• TMS

Trial Overview The study tests if adding intermittent theta burst stimulation (iTBS) to regular treatment helps improve PTSD symptoms. iTBS will be applied to a brain region called the right dorsolateral prefrontal cortex during the second week of treatment, compared with a sham (placebo-like) procedure.

How Is the Trial Designed?

Group I: Active TMS Active Control 1 Intervention

Group II: Sham Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

In a study of 770 veterans with major depressive disorder (MDD), TMS treatment led to significant reductions in both MDD and PTSD symptoms, with a response rate of 41.4% and remission rate of 20% for MDD after receiving an adequate dose of 30 sessions.

The treatment was found to be safe, with side effects aligning with the known safety profile of TMS, and 65.3% of veterans with comorbid PTSD experienced clinically meaningful symptom reductions, indicating TMS's effectiveness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prefrontal transcranial magnetic stimulation for depression in US military veterans - A naturalistic cohort study in the veterans health administration. Madore, MR., Kozel, FA., Williams, LM., et al.[2023]

In a study of 20 male combat veterans with treatment-resistant PTSD, repetitive transcranial magnetic stimulation (rTMS) significantly reduced hyperarousal symptoms, suggesting its potential effectiveness for this specific symptom.

However, rTMS did not show significant improvements in overall PTSD symptoms or co-occurring depression and anxiety scores, indicating that while it may help with hyperarousal, further research is needed to understand its broader efficacy in PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is transcranial magnetic stimulation effective in treatment-resistant combat related posttraumatic stress disorder? Oznur, T., Akarsu, S., Celik, C., et al.[2014]

Repetitive transcranial magnetic stimulation (rTMS) is a safe treatment option for depression and shows potential for alleviating symptoms of post-traumatic stress disorder (PTSD), particularly when applied to the right dorsolateral prefrontal cortex.

High-frequency rTMS appears to be more effective than low-frequency rTMS in treating PTSD symptoms, possibly by increasing levels of brain-derived neurotrophic factor, which supports brain health and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation treatment for post-traumatic stress disorder]. Jensen, BS., Ashkanian, M.[2018]

Repetitive transcranial magnetic stimulation (rTMS) was found to be significantly more effective than sham treatment in reducing PTSD symptoms and depression severity, with a standardized mean difference of -1.13 for PTSD and -0.83 for depression.

While high-frequency (HF) rTMS showed slightly better outcomes compared to low-frequency (LF) rTMS, the overall quality of evidence was rated very low due to factors like small sample sizes and inconsistent results, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in repetitive transcranial magnetic stimulation for posttraumatic stress disorder: A systematic review. Belsher, BE., Beech, EH., Reddy, MK., et al.[2021]

In a study involving 18 patients with PTSD, low-frequency repetitive transcranial magnetic stimulation (rTMS) to the right prefrontal cortex significantly improved overall PTSD symptoms, particularly in re-experiencing and total scores on the Clinician-Administered PTSD Scale (CAPS).

The results suggest that rTMS is a safe and effective treatment option for PTSD, with a notable impact on specific symptom clusters, indicating potential for further research into optimizing rTMS protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-frequency, Repetitive Transcranial Magnetic Stimulation for the Treatment of Patients with Posttraumatic Stress Disorder: a Double-blind, Sham-controlled Study. Nam, DH., Pae, CU., Chae, JH.[2021]

Bilateral sequential theta-burst stimulation (bsTBS) was well tolerated in a small study of 8 military veterans with treatment-resistant depression (TRD) and comorbid PTSD, showing promising remission rates of 25% and response rates of 38% for depression scores.

The study suggests that bsTBS may be a viable therapeutic option for patients with TRD and PTSD, indicating the need for larger studies to further evaluate its efficacy compared to other rTMS treatment paradigms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral sequential theta burst stimulation in depressed veterans with service related posttraumatic stress disorder: a feasibility study. Vaithianathan, T., Blair, M., Soares, V., et al.[2022]

In a study involving 24 PTSD patients, high-frequency repetitive transcranial magnetic stimulation (rTMS) at 10 Hz significantly improved core PTSD symptoms and alleviated anxiety over 10 daily sessions.

The results indicate that rTMS targeting the right dorsolateral prefrontal cortex is more effective than low-frequency or sham stimulation, suggesting its potential as a therapeutic intervention for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the right dorsolateral prefrontal cortex in posttraumatic stress disorder: a double-blind, placebo-controlled study. Cohen, H., Kaplan, Z., Kotler, M., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has been shown to be effective for treatment-resistant major depressive disorder (trMDD), but there is limited evidence for its use in patients with comorbid posttraumatic stress disorder (PTSD).

In a unique case, a patient with both trMDD and PTSD experienced remission of symptoms after receiving rTMS targeting the left dorsolateral prefrontal cortex, suggesting potential benefits of rTMS in this specific population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report of a 24-year-old man with resolution of treatment-resistant major depressive disorder and comorbid PTSD using rTMS. Nakama, H., Garcia, A., O'Brien, K., et al.[2015]

Transcranial magnetic stimulation (TMS) has been found to be an effective treatment for post-traumatic stress disorder (PTSD), with a meta-analysis of three studies showing a significant reduction in PTSD symptoms.

The treatment is generally well tolerated, and right-sided TMS may be more effective than left-sided, although further research is needed to optimize treatment parameters and understand potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the effectiveness of transcranial magnetic stimulation for post-traumatic stress disorder. Karsen, EF., Watts, BV., Holtzheimer, PE.[2018]

A study of 77 military patients receiving rTMS treatment showed significant reductions in depression and PTSD symptoms, with over 44% of patients experiencing a notable decrease in depression scores after treatment.

Most patients had previously tried multiple antidepressants (average of 2.7 trials), indicating that rTMS may be an effective alternative for those with treatment-resistant depression and comorbid PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of rTMS on Refractory Depression and Comorbid PTSD Symptoms at a Military Treatment Facility. Wilkes, S., Ona, C., Yang, M., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Citations

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

Transcranial Magnetic Stimulation for Post-traumatic Stress ... Overall, TMS therapy has been suggested as an effective treatment in PTSD patients. ... A meta-analysis performed looked at PTSD mood outcomes with the use of TMS ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016503272100327X

Transcranial magnetic stimulation as a treatment for ... TMS shows potential as a treatment for PTSD, although further research is required to understand the neurological mechanisms of TMS on specific PTSD symptoms.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02981381

Synchronized Transcranial Magnetic Stimulation for PTSD It is hypothesized that sTMS will be effective for PTSD and mood symptoms. Detailed Description. Posttraumatic stress disorder (PTSD) is a highly prevalent ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12452984/

The Effects of Repetitive Transcranial Magnetic Stimulation on ... One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder. Neuropsychopharmacology. 2020;45(6):940–946 ...

5. 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39092744/

Repetitive transcranial magnetic stimulation for post- ... Our review suggests that active rTMS probably makes little to no difference to PTSD severity immediately following treatment compared to sham stimulation.

7. sciencedirect.com sciencedirect.com/science/article/pii/S109471592201399X

Repetitive Transcranial Magnetic Stimulation for ... Veterans with mTBI had greater PTSD symptoms, yet neither TBI status nor cumulative head injuries reduced TMS effectiveness.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02990793

Clinical Trial to Evaluate the Safety and Efficacy of MeRT ... MERT-005-B is a prospective, double blind, randomized, sham-controlled, parallel group, stratified, adaptive clinical trial designed to evaluate the ...

9. 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 ...