Transcranial Magnetic Stimulation for PTSD

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial magnetic stimulation (TMS) can help veterans and active-duty service members with PTSD. TMS uses magnetic fields to stimulate specific parts of the brain, and researchers aim to determine if it can reduce PTSD symptoms independently. Participants must have a PTSD diagnosis and be able to attend all clinic appointments. The goal is to discover a new treatment for PTSD that is easier and more accessible for those who have struggled with traditional therapies. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to more accessible 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 prior data suggests that this transcranial magnetic stimulation is safe for PTSD treatment?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe. TMS uses magnetic fields to stimulate nerve cells in the brain and is used in both research and medical settings. It is considered safe when guidelines are followed.

Studies on a specific type of TMS, called image-guided robotically delivered TMS, have shown promise for helping people with PTSD (post-traumatic stress disorder). While specific data on side effects for this treatment is not yet available, TMS is usually well-tolerated. Common side effects, if they occur, are usually mild and include headaches or discomfort on the scalp where the treatment is applied.

As this trial is in an early stage, researchers are still collecting information on using this treatment alone for PTSD. Prospective participants should discuss any concerns with the research team, who can provide more detailed information on potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Image-Guided Robotically Delivered Transcranial Magnetic Stimulation (IR-TMS) for PTSD because it uses a cutting-edge method of precisely targeting the brain. Unlike traditional treatments like medication and talk therapy, IR-TMS delivers magnetic pulses directly to the right dorsolateral prefrontal cortex (DLPFC), an area linked to mood regulation. This precision is achieved using a robotic arm and advanced imaging for guidance, which could mean more effective and faster symptom relief compared to existing options. Additionally, the use of a theta burst stimulation protocol allows for multiple sessions in a short period, potentially accelerating recovery.

What evidence suggests that image-guided transcranial magnetic stimulation is effective for PTSD?

Research has shown that transcranial magnetic stimulation (TMS) can help reduce PTSD symptoms. In this trial, participants will receive Image-Guided Robotically Delivered Transcranial Magnetic Stimulation (IR-TMS) to the right DLPFC. A recent study demonstrated that combining TMS with an intensive PTSD therapy program yielded promising results. Participants who received both treatments improved more than those who only had the therapy or a sham treatment. While researchers continue to study the effectiveness of TMS alone, earlier research suggests that TMS is safe and may help reduce PTSD symptoms in military personnel. This treatment uses magnets to stimulate brain areas involved in mood and behavior, potentially easing PTSD symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Felipe S Salinas, Ph.D.

Principal Investigator

University of Texas Health at San Antonio

Are You a Good Fit for This Trial?

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 fluent in English.

I have been diagnosed with PTSD.

I can attend all clinic appointments.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Trauma Research and Combat Casualty Care Collaborative

Collaborator

Published Research Related to This Trial

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 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 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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06587659

Study Details | NCT06587659 | Accelerated Image-Guided ... Findings from this open-label trial of IR-TMS for PTSD will serve as preliminary data for a larger randomized clinical trial to further identify the stand-alone ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11224515/

A retrospective chart review to assess the impact of alpha ... This data provides preliminary support for safe application of α-rTMS for symptom reduction in active-duty special operations military personnel.

3. strongstar.org strongstar.org/research/strongstar/image-guided-robotically-delivered-transcranial-magnetic-stimulation-for-combat-r/

Image-guided Robotically Delivered Transcranial Magnetic ... Test active duty military personnel and veterans for PTSD symptom improvements resulting from electromagnetic stimulation to the brain; test for changes in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02853032

Study Details | NCT02853032 | Image-guided, Robotically ... The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06587659/accelerated-image-guided-robotically-delivered-transcranial-magnetic-stimulation-for-combat-ptsd

Accelerated Image-Guided Robotically Delivered ... The newest study from the our team aimed to augment PE residential treatment with a neuromodulatory treatment: image-guided, robot-navigated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11227799/

Efficacy of MRI-guided rTMS for post-traumatic stress disorder ... This is a randomised controlled clinical trial to investigate the efficacy of MRI-guided repetitive transcranial magnetic stimulation (rTMS) for ...

7. trialx.com trialx.com/clinical-trials/listings/323872/accelerated-image-guided-robotically-delivered-transcranial-magnetic-stimulation-for-combat-ptsd/

Accelerated Image-Guided Robotically Delivered ... Posttraumatic stress disorder (PTSD) among military service members and veterans is as high as 32% and is the third most service-connected ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1388245720305149

Safety and recommendations for TMS use in healthy ... The meeting intended to update the ten-year-old safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical ...