Transcranial Magnetic Stimulation for PTSD
Recruiting in Palo Alto (17 mi)
Overseen byFelipe S Salinas, Ph.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Disqualifiers: Bipolar, Schizophrenia, Substance abuse, others
No Placebo Group
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.
12345Is 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.
14678How 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.
124910Eligibility 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.
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: IR-TMS to the right DLPFCExperimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research Imaging InstituteSan Antonio, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
References
Is transcranial magnetic stimulation effective in treatment-resistant combat related posttraumatic stress disorder? [2014]To examine the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with treatment-resistant posttraumatic stress disorder (PTSD) with co-occurring major depression.
Exposure Therapy and Simultaneous Repetitive Transcranial Magnetic Stimulation: A Controlled Pilot Trial for the Treatment of Posttraumatic Stress Disorder. [2020]This is a small preliminary but novel study assessing the feasibility of repetitive transcranial magnetic stimulation (rTMS) delivery to veterans with posttraumatic stress disorder (PTSD) while they simultaneously receive prolonged exposure (PE) therapy.
Repetitive TMS to augment cognitive processing therapy in combat veterans of recent conflicts with PTSD: A randomized clinical trial. [2018]The objective was to test whether repetitive Transcranial Magnetic Stimulation (rTMS) just prior to Cognitive Processing Therapy (CPT) would significantly improve the clinical outcome compared to sham rTMS prior to CPT in veterans with PTSD.
Repetitive transcranial magnetic stimulation of the right dorsolateral prefrontal cortex in posttraumatic stress disorder: a double-blind, placebo-controlled study. [2022]The efficacy of repetitive transcranial magnetic stimulation (rTMS) of the right prefrontal cortex was studied in patients with posttraumatic stress disorder (PTSD) under double-blind, placebo-controlled conditions.
Advances in repetitive transcranial magnetic stimulation for posttraumatic stress disorder: A systematic review. [2021]Repetitive transcranial magnetic stimulation (rTMS) as a treatment for posttraumatic stress disorder (PTSD) has gained interest over the past two decades. However, it has yet to be recommended in major treatment guidelines. We conducted a systematic review of randomized controlled trials to examine the efficacy of rTMS for PTSD. Thirteen studies with 549 participants were included in this review. We compared the effects of (1) rTMS versus sham, and (2) high-frequency (HF) versus low-frequency (LF) rTMS, on posttreatment PTSD scores and other secondary outcomes. We calculated the standardized mean differences (SMD) to determine the direction of effects, and unstandardized mean differences to estimate the magnitude of efficacy. At post-treatment, rTMS was superior to sham comparison in reducing PTSD (SMD = -1.13, 95% CI: -2.10 to -0.15) and depression severity (SMD = -0.83, 95% CI: -1.30 to -0.36). The quality of evidence, however, was rated very low due to small samples sizes, treatment heterogeneity, inconsistent results, and an imprecise pooled effect. HF rTMS was associated with slightly improved, albeit imprecise, outcomes compared to LF rTMS on PTSD (SMD = -0.19, 95% CI: -1.39 to 1.00) and depression (SMD = -1.09, 95% CI: -1.65 to -0.52) severity. Further research is required to advance the evidence on this treatment.
Prefrontal transcranial magnetic stimulation for depression in US military veterans - A naturalistic cohort study in the veterans health administration. [2023]Repetitive transcranial magnetic stimulation (TMS) is an evidence-based treatment for pharmacoresistant major depressive disorder (MDD), however, the evidence in veterans has been mixed. To this end, VA implemented a nationwide TMS program that included evaluating clinical outcomes within a naturalistic design. TMS was hypothesized to be safe and provide clinically meaningful reductions in MDD and posttraumatic stress disorder (PTSD) symptoms.
Image-guided TMS is safe in a predominately pediatric clinical population. [2022]The safety of transcranial magnetic stimulation (TMS) has been previously evaluated in healthy volunteers and clinical adult populations. We sought to fill the gap in safety of TMS functional mapping in a clinical, predominately pediatric cohort.
Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder. [2022]Post-traumatic stress disorder (PTSD) is a psychiatric disorder that causes significant functional impairment and is related to altered stress response and reinforced learned fear behavior. PTSD has been found to impact three functional networks in the brain: default mode, executive control, and salience. The executive control network includes the dorsolateral prefrontal cortex (DLPFC) and lateral PPC. The salience network involves the anterior cingulate cortex, anterior insula, and amygdala. This latter network has been found to have increased functional connectivity in PTSD. Transcranial Magnetic Stimulation (TMS) is a technique used in treating PTSD and involves stimulating specific portions of the brain through electromagnetic induction. Currently, high-frequency TMS applied to the left dorsolateral prefrontal cortex (DLPFC) is approved for use in treating major depressive disorder (MDD) in patients who have failed at least one medication trial. In current studies, high-frequency stimulation has been shown to be more effective in PTSD rating scales posttreatment than low-frequency stimulation. The most common side effect is headache and scalp pain treated by mild analgesics. Seizures are a rare side effect and are usually due to predisposing factors. Studies have been done to assess the overall efficacy of TMS. However, results have been conflicting, and sample sizes were small. More research should be done with larger sample sizes to test the efficacy of TMS in the treatment of PTSD. Overall, TMS is a relatively safe treatment. Currently, the only FDA- approved to treat refractory depression, but with the potential to treat many other conditions.
Noninvasive brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic stimulation treatment for posttraumatic stress disorder. [2021]We aimed to investigate the efficacy of 20 Hz repetitive transcranial magnetic stimulation (rTMS) of either right or left dorsolateral prefrontal cortex (DLPFC) as compared to sham rTMS for the relief of posttraumatic stress disorder (PTSD)-associated symptoms.
[Repetitive transcranial magnetic stimulation treatment for post-traumatic stress disorder]. [2018]Approximately 10% of combat soldiers and 30% of rape victims develop post-traumatic stress disorder (PTSD). Repetitive transcranial magnetic stimulation (rTMS) is already known to be safe in depression treatment. Research results of the past 15 years indicate that rTMS induced to the right dorsolateral prefrontal cortex may have a potential to treat the symptoms of PTSD. Furthermore, high-frequency rTMS seems to be superior to low-frequency rTMS. The effect of rTMS on PTSD symptoms could be mediated by increasing the level of brain-derived neurotrophic factor.