Transcranial Magnetic Stimulation for PTSD

Overseen By Felipe S Salinas, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Bipolar, Schizophrenia, Substance abuse, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Posttraumatic stress disorder (PTSD) among military service members and veterans is as high as 32% and is the third most service-connected disability, resulting in over $1.5 billion in direct costs over a five-year period. According to Clinical Practice Guidelines, strong evidence exists for psychotherapies, such as prolonged exposure (PE) for PTSD. However, psychotherapies are often met with high drop-out rates, treatment non-compliance, and emotional stress due to trauma recall. A successful approach to reduce drop-out rates and maintain efficacy is to compress psychotherapy into daily, day-long PE sessions. Yet another deficit exists regarding the feasibility of this approach outside of residential treatment facilities, which are typically reserved for the most extreme cases. The newest study from the our team aimed to augment PE residential treatment with a neuromodulatory treatment: image-guided, robot-navigated transcranial magnetic stimulation (IR-TMS). Along with the PE-focused intensive inpatient program (IIP-PE), participants received IR-TMS targeting the right dorsolateral prefrontal cortex (DLPFC) daily for 20 consecutive days. Results demonstrated superiority of the combined IIP-PE/IR-TMS approach, compared to IIP-PE and a sham condition. However, it is not yet established whether a standalone IR-TMS approach will achieve similar results. Our goal is to implement an open-label trial of IR-TMS for PTSD, in which veterans and active-duty service members with PTSD will receive accelerated IR-TMS throughout a 2-week timeframe. Results will be used as a foundation for future extramural funding to scale-up the stand alone IR-TMS intervention for PTSD treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for PTSD?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can help reduce symptoms of PTSD and depression, with studies indicating it is more effective than a placebo. However, the evidence is considered low quality due to small study sizes and inconsistent results, so more research is needed. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS) is generally considered safe for humans, with the most common side effects being mild headaches and scalp pain, which can be treated with over-the-counter pain relievers. Seizures are a rare side effect and usually occur in people with predisposing factors. TMS has been evaluated for safety in both adults and children. ^{1 4 6 7 8}

How is Image-Guided Robotically Delivered Transcranial Magnetic Stimulation different from other PTSD treatments?

This treatment is unique because it uses a robot to precisely deliver magnetic pulses to specific areas of the brain, potentially improving the effectiveness of transcranial magnetic stimulation (TMS) for PTSD. Unlike traditional methods, this approach may offer more accurate targeting, which could enhance treatment outcomes. ^{1 2 4 9 10}

Research Team

Felipe S Salinas, Ph.D.

Principal Investigator

University of Texas Health at San Antonio

Eligibility Criteria

This trial is for veterans and active-duty service members aged 18-65 with PTSD, who can attend all appointments and are fluent in English. It's not specified who cannot join, but typically those with conditions that interfere with the treatment or assessments would be excluded.

Inclusion Criteria

I am between 18 and 65 years old.

I am fluent in English.

I can attend all clinic appointments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IR-TMS targeting the right dorsolateral prefrontal cortex for 2 weeks, with up to 4 sessions per day, 5 days a week

2 weeks

Daily sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 1-month and 3-month intervals

12 weeks

Assessments at 1-month and 3-month intervals

Treatment Details

Interventions

• Image-Guided Robotically Delivered Transcranial Magnetic Stimulation

Trial Overview The study tests accelerated transcranial magnetic stimulation (TMS) delivered by a robotic arm to treat PTSD. Participants will receive TMS targeting their brain's right dorsolateral prefrontal cortex daily over two weeks to see if it improves their symptoms.

Participant Groups

Group I: IR-TMS to the right DLPFC Experimental Treatment 2 Interventions

IR-TMS will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the IR-TMS coil positioned using a robotic arm. In this arm, active IR-TMS will be delivered using a theta burst stimulation protocol (i.e. 1,800 pulses/session), 4 sessions per day, 5 days/week, for 2 weeks.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

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]

This pilot study involving 8 veterans with PTSD shows that combining repetitive transcranial magnetic stimulation (rTMS) with prolonged exposure (PE) therapy is safe and feasible, with a dropout rate similar to traditional PE therapy.

While the overall improvement in PTSD symptoms was not statistically significant, veterans with comorbid major depression experienced notable benefits from rTMS, suggesting potential for enhanced treatment outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure Therapy and Simultaneous Repetitive Transcranial Magnetic Stimulation: A Controlled Pilot Trial for the Treatment of Posttraumatic Stress Disorder. Fryml, LD., Pelic, CG., Acierno, R., et al.[2020]

In a study involving 103 veterans with combat-related PTSD, those who received repetitive Transcranial Magnetic Stimulation (rTMS) before Cognitive Processing Therapy (CPT) experienced significantly greater reductions in PTSD symptoms compared to those who received sham rTMS.

The benefits of combining rTMS with CPT were not only evident during treatment but also sustained for up to six months after the therapy, indicating a lasting impact on symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive TMS to augment cognitive processing therapy in combat veterans of recent conflicts with PTSD: A randomized clinical trial. Kozel, FA., Motes, MA., Didehbani, N., et al.[2018]

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) 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 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 involving 429 pediatric patients undergoing transcranial magnetic stimulation (TMS) for motor and language mapping, most adverse events were benign, with seizures occurring in 5.8% of sessions but not conclusively linked to TMS.

TMS was safely performed in patients with cranial metal, and useful mapping results were achieved in nearly all cases, indicating that TMS is a safe option for functional mapping in pediatric patients with epilepsy or brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. Braden, AA., Weatherspoon, SE., Boardman, T., et al.[2022]

Transcranial Magnetic Stimulation (TMS) shows promise as a treatment for PTSD, particularly with high-frequency stimulation of the left dorsolateral prefrontal cortex, which has been found to be more effective than low-frequency stimulation in improving PTSD symptoms.

TMS is generally safe, with headaches being the most common side effect, while serious side effects like seizures are rare and usually linked to pre-existing conditions; however, more extensive research with larger sample sizes is needed to confirm its efficacy for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder. Edinoff, AN., Hegefeld, TL., Petersen, M., et al.[2022]

In a study involving 30 patients with PTSD, both left and right dorsolateral prefrontal cortex (DLPFC) stimulation using 20 Hz rTMS significantly reduced PTSD symptoms, with right DLPFC stimulation showing a larger effect.

The treatment was safe, with no cognitive worsening observed, and the benefits lasted for at least three months after the treatment, suggesting that rTMS could be an effective long-term intervention for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic stimulation treatment for posttraumatic stress disorder. Boggio, PS., Rocha, M., Oliveira, MO., et al.[2021]

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]

References

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

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

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

Exposure Therapy and Simultaneous Repetitive Transcranial Magnetic Stimulation: A Controlled Pilot Trial for the Treatment of Posttraumatic Stress Disorder. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Repetitive TMS to augment cognitive processing therapy in combat veterans of recent conflicts with PTSD: A randomized clinical trial. [2018]

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. England pubmed.ncbi.nlm.nih.gov

Advances in repetitive transcranial magnetic stimulation for posttraumatic stress disorder: A systematic review. [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. Netherlands pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder. [2022]

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

Noninvasive brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic stimulation treatment for posttraumatic stress disorder. [2021]

10. Denmark pubmed.ncbi.nlm.nih.gov

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