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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment TMS for Post-Traumatic Stress Disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can reduce symptoms of PTSD and depression more effectively than a placebo treatment. However, the evidence is not very strong due to small study sizes and inconsistent results, so more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is TMS safe for treating PTSD?

TMS, including its repetitive form (rTMS), has been studied for over two decades and is considered safe for treating conditions like depression and PTSD. Safety guidelines have been established and updated over the years, with no major changes, indicating a consistent safety profile. It is important to screen for any precautions and risks before treatment, but generally, TMS is well-tolerated. ^{2 6 7 8 9}

How does TMS treatment for PTSD differ from other treatments?

Transcranial magnetic stimulation (TMS) is unique for PTSD as it uses magnetic fields to stimulate nerve cells in the brain, specifically targeting the right prefrontal cortex, which is different from traditional treatments like medication or talk therapy. This non-invasive approach offers an alternative for those who may not respond well to standard treatments. ^{4 5 9 10 11}

What is the purpose of this trial?

The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD. Specifically, the present study will compare iTBS versus a sham condition during the second week of the 2- week IOP for veterans who have not experienced PTSD symptom reductions over the course of the first week of the Road Home Program intensive PTSD treatment program.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Is transcranial magnetic stimulation effective in treatment-resistant combat related posttraumatic stress disorder? [2014]

2. Denmark pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation treatment for post-traumatic stress disorder]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Advances in repetitive transcranial magnetic stimulation for posttraumatic stress disorder: A systematic review. [2021]

4. United States 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. [2022]

5. Korea (South) 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. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Prefrontal transcranial magnetic stimulation for depression in US military veterans - A naturalistic cohort study in the veterans health administration. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Impacts of rTMS on Refractory Depression and Comorbid PTSD Symptoms at a Military Treatment Facility. [2021]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Review of the effectiveness of transcranial magnetic stimulation for post-traumatic stress disorder. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Bilateral sequential theta burst stimulation in depressed veterans with service related posttraumatic stress disorder: a feasibility study. [2022]

11. United States 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. [2015]