CPT + rTMS for PTSD
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byJohn Hart, Jr., MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas at Dallas
Must not be taking: Seizure-threshold lowering drugs
Disqualifiers: Epilepsy, Substance use, Psychotic disorder, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.
Will I have to stop taking my current medications?
The trial requires participants to stop taking any medication that significantly lowers the seizure threshold. If you are on such medications, you would need to discontinue them to participate.
What data supports the effectiveness of the treatment CPT + rTMS for PTSD?
Research suggests that repetitive transcranial magnetic stimulation (rTMS) can help reduce PTSD symptoms, especially when combined with therapies like Cognitive Processing Therapy (CPT). Studies have shown that rTMS is more effective than a placebo in reducing PTSD and depression severity, although more research is needed to confirm these findings.
12345Is rTMS safe for humans?
Repetitive Transcranial Magnetic Stimulation (rTMS) has been studied for over two decades and is considered safe for treating depression, with safety guidelines established and updated over the years. It has been used in various conditions, including PTSD, with no substantial changes in safety guidelines, indicating its general safety in humans.
25678How does the treatment CPT + rTMS for PTSD differ from other treatments for this condition?
CPT + rTMS for PTSD is unique because it combines Cognitive Processing Therapy (CPT), a type of talk therapy, with repetitive Transcranial Magnetic Stimulation (rTMS), which uses magnetic fields to stimulate nerve cells in the brain. This combination aims to enhance the effectiveness of therapy by potentially improving brain function related to PTSD symptoms, offering a novel approach compared to traditional therapies that do not include brain stimulation.
235910Eligibility Criteria
This trial is for post-9/11 veterans with combat-related PTSD. Participants must not have had recent trauma, high suicide risk, seizures, major head injuries, severe substance use in the past 3 months, certain brain conditions or metal implants near the head. Pregnant/nursing individuals and those on seizure-lowering meds are excluded.Inclusion Criteria
You are a military veteran who served in conflicts after September 11, and you have been diagnosed with post-traumatic stress disorder (PTSD) specifically related to combat during that time.
Exclusion Criteria
I experienced a traumatic event within the last 3 months.
cardiac pacemaker, implanted medication pumps of any sort that would increase the risk of rTMS
I cannot stop taking medication that increases my risk of seizures.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 1 Hz rTMS to the rDLPFC prior to each of 12 Cognitive Processing Therapy (CPT) sessions or sham rTMS with CPT, or rTMS alone over 12 sessions
12 weeks
1 session per week
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 1-month, 6-months, and 12-months post-treatment
12 months
3 visits (in-person)
Participant Groups
The study tests combining repetitive Transcranial Magnetic Stimulation (rTMS) with Cognitive Processing Therapy (CPT) to treat PTSD symptoms. It also looks at changes in depression levels, social functioning and brain activity through EEGs and MRIs.
3Treatment groups
Active Control
Placebo Group
Group I: Active rTMS AloneActive Control1 Intervention
30 minutes of 1 Hz rTMS to rDLPFC at 1 session per week over 12 weeks
Group II: Active rTMS + CPTActive Control2 Interventions
30 minutes of 1 Hz rTMS to rDLPFC prior to each CPT session
Group III: Sham rTMS + CPTPlacebo Group2 Interventions
30 minutes of sham repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) prior to each Cognitive Processing Therapy (CPT) session
Active rTMS is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Smoking Cessation
- Chronic Pain Syndrome
🇪🇺 Approved in European Union as rTMS for:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Chronic Pain Syndrome
- Generalized Anxiety Disorder (GAD)
- Bipolar Disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Florida State University College of MedicineTallahassee, FL
Metrocare Services of DallasAddison, TX
The University of Texas at DallasDallas, TX
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Who Is Running the Clinical Trial?
The University of Texas at DallasLead Sponsor
Metrocare Services of DallasCollaborator
Johns Hopkins UniversityCollaborator
Florida State UniversityCollaborator
University of Texas Southwestern Medical CenterCollaborator
References
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.
[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.
Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. [2012]Using the event-related potential P3a component as a marker, the authors tested the efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing hyperarousability to specific threat stimuli in one Vietnam veteran with chronic posttraumatic stress disorder (PTSD), who exhibited an exaggerated P3a response to combat-related pictures. Twenty minutes of 1-Hz rTMS to the right prefrontal area effected a reduction in the P3a amplitude, whereas similar rTMS to the left prefrontal area did not. In addition to providing evidence for the effectiveness of right frontal rTMS for an exaggerated response to trauma-related stimuli, this study provides electrophysiological corroboration of subjective reports of PTSD symptoms.
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.
Impacts of rTMS on Refractory Depression and Comorbid PTSD Symptoms at a Military Treatment Facility. [2021]Repetitive transcranial magnetic stimulation (rTMS) as a treatment for depression has been studied for over two decades. Repetitive TMS was approved by the Food and Drug Administration in 2008 for the treatment of depression after at least one failed trial of an antidepressant medication of adequate dose and duration. This study evaluated whether rTMS treatments may be associated with measurable improvements in depression and post-traumatic stress disorder (PTSD) symptoms for treated military beneficiaries in Hawaii suffering from depression. It also examined the number of failed medication trials that patients underwent before rTMS treatment.
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.
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.
Bilateral sequential theta burst stimulation in depressed veterans with service related posttraumatic stress disorder: a feasibility study. [2022]Depression comorbid with posttraumatic stress disorder (PTSD) can be disabling and treatment resistant. Preliminary evidence suggests that repetitive transcranial magnetic stimulation (rTMS), may have a role in helping these patients. There are only few published studies using different rTMS paradigms including bilateral intermittent theta burst (iTBS) and low frequency rTMS.
Repetitive transcranial magnetic stimulation treatment of comorbid posttraumatic stress disorder and major depression. [2006]Twelve patients with comorbid posttraumatic stress disorder (PTSD) and major depression underwent repetitive transcranial magnetic stimulation (rTMS) to left frontal cortex as an open-label adjunct to current antidepressant medications. rTMS parameters were as follows: 90% of motor threshold, 1 Hz or 5 Hz, 6,000 stimuli over 10 days. Seventy-five percent of the patients had a clinically significant antidepressant response after rTMS, and 50% had sustained response at 2-month follow-up. Comparable improvements were seen in anxiety, hostility, and insomnia, but only minimal improvement in PTSD symptoms. Left frontal cortical rTMS may have promise for treating depression in PTSD, but there may be a dissociation between treating mood and treating core PTSD symptoms.