eTMS for PTSD
Recruiting in Palo Alto (17 mi)
Overseen byWynn Legon, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Virginia Polytechnic Institute and State University
Must not be taking: Certain medications
Disqualifiers: Claustrophobia, Pregnancy, Epilepsy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.
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 exclude participants on certain medications. It's best to discuss your specific medications with the trial coordinators.
What data supports the effectiveness of the treatment eTMS for PTSD?
Research shows that repetitive transcranial magnetic stimulation (rTMS), a component of eTMS, has been effective in treating major depression and has shown some promise in improving symptoms of PTSD, especially when combined with other therapies like Cognitive Processing Therapy.
12345Is eTMS (or TMS) safe for humans?
Repetitive transcranial magnetic stimulation (rTMS), which is similar to eTMS, is considered safe for treating conditions like depression and PTSD. Research over the past 15 years supports its safety, especially when targeting specific brain areas.
24678How is the eTMS treatment for PTSD different from other treatments?
eTMS (EEG-enhanced Transcranial Magnetic Stimulation) is unique because it combines brain stimulation with EEG (a test that measures electrical activity in the brain) to potentially enhance treatment outcomes. Unlike traditional therapies, it uses magnetic fields to stimulate specific brain areas, which may help improve PTSD symptoms by targeting brain activity directly.
12379Eligibility Criteria
This trial is for veterans and first responders who have been diagnosed with PTSD. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.Inclusion Criteria
Veteran or first responder diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above
Exclusion Criteria
Claustrophobia
Pregnant
Unable to calculate EEG alpha frequency
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-Treatment Testing
Participants undergo 2 days of extensive testing including MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study
1 week
2 visits (in-person)
Treatment
Participants receive either active or sham eTMS application
5 weeks
Post-Treatment Testing
Participants undergo 2 days of extensive testing after eTMS application, including MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study
1 week
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests eTMS, a personalized brain stimulation treatment, on individuals with PTSD. It's a double-blind trial meaning neither the participants nor the researchers know who gets real treatment or placebo. The effects are measured before and after treatment.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: eTMSExperimental Treatment1 Intervention
The active side of a TMS coil will be used to administer eTMS application.
Group II: eTMS shamPlacebo Group1 Intervention
The sham side of a TMS coil will be used to administer a sham dosage of eTMS application.
eTMS is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as TMS for:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Migraines
- Anxiety with depression
- Smoking dependence
- Bipolar depression
- Depression in adolescents 15 years and older
🇪🇺 Approved in European Union as TMS for:
- Depression
- Obsessive-Compulsive Disorder (OCD)
- Migraines
- Anxiety disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fralin Biomedical Research InstituteRoanoke, VA
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Who Is Running the Clinical Trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
Wave NeuroscienceIndustry Sponsor
References
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.
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.
Use of machine learning in predicting clinical response to transcranial magnetic stimulation in comorbid posttraumatic stress disorder and major depression: A resting state electroencephalography study. [2021]Repetitive transcranial magnetic stimulation (TMS) is clinically effective for major depressive disorder (MDD) and investigational for other conditions including posttraumatic stress disorder (PTSD). Understanding the mechanisms of TMS action and developing biomarkers predicting response remain important goals. We applied a combination of machine learning and electroencephalography (EEG), testing whether machine learning analysis of EEG coherence would (1) predict clinical outcomes in individuals with comorbid MDD and PTSD, and (2) determine whether an individual had received a TMS course.
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.
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.
Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. [2015]Cranial electrotherapy stimulation (CES) is being prescribed for service members and veterans for the treatment of anxiety, posttraumatic stress disorder (PTSD), insomnia and depression. The purpose of this study was to examine service members' and veterans' perceptions of the effectiveness and safety of CES treatment. Service members and veterans (N=1,514) who had obtained a CES device through the Department of Defense or Veterans Affairs Medical Center from 2006-2011 were invited to participate in the web based survey via email. One hundred fifty-two participants returned questionnaires. Data were analyzed using descriptive statistics. Participants reported clinical improvement of 25% or more from using CES for anxiety (66.7%), PTSD (62.5%), insomnia (65.3%) and depression (53.9%). The majority of these participants reported clinical improvement of 50% or more. Respondents also perceived CES to be safe (99.0%). Those individuals who were not taking any prescription medication rated CES more effective than the combined CES and prescription medication group. CES provides service members and veterans with a safe, noninvasive, nondrug, easy to use treatment for anxiety, PTSD, insomnia, and depression that can be used in the clinical setting or self-directed at home.
[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 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.
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.