Synchronized Transcranial Magnetic Stimulation for PTSD
Completed · Not applicable · Has a placebo group
Conditions studied: PTSD, Depression
In brief
The investigators propose a small, two-site, sham-controlled pilot study of synchronized Transcranial Magnetic Stimulation (sTMS) in patients with comorbid post-traumatic stress disorder (PTSD) and depression. It is hypothesized that sTMS will be effective for PTSD and mood symptoms.
Key facts
- Study ID
- NCT02981381
- Run by
- Providence VA Medical Center
- People needed
- 23
- Starts
- 2016-10-13
- Expected to finish
- 2018-10-26
- Last updated by the study team
- 2025-06-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must be a Veteran;
- MRI safe;
- Meet Diagnostic and Statistical Manual, Fifth Edition (DSM 5) criterion for PTSD (acute or chronic, confirmed by the Clinician Administered PTSD Scale (CAPS) and at least moderate severity defined by a PCL-5 score > 33); AND at least moderate depressive symptom severity (defined by QIDS-SR score > or equal to 11) at baseline visit. Individuals with bipolar II or otherwise unspecified who are currently in a depressed episode are eligible;
- Baseline score of "moderately ill" or worse on the Clinical Global Impressions-Severity (CGI-S);
- Stable psychotropic regimen for at least 6 weeks prior to baseline and willing to maintain current dose and regimen throughout study, or no psychotropic medication at all;
- If female and of child bearing potential, must agree to use an acceptable method of birth control for the duration of the study treatment period;
- Be willing and able to comply with all study related procedures and visits;
- Be capable of independently reading and understanding all patient information materials and giving written informed consent.
You may not qualify if…
- Pregnant or lactating, or planning on becoming pregnant within the next 3 months;
- Lifetime history of loss of consciousness (>10 minutes) due to head injury, or lifetime history of head injury with documented evidence of brain injury;
- Current (or past) significant neurological disorders (seizure disorder, primary or secondary central nervous system (CNS) tumors, stroke, cerebral aneurysm);
- Unstable medical illness, or significant absence of appropriate medical care;
- Current axis I primary psychotic disorder or Bipolar I disorder;
- Active (within the last month) moderate or severe substance (excluding nicotine/caffeine) abuse disorders. Individuals on stable (>3 months), monitored opiate agonist therapy may be included at investigator's discretion;
- Past failed treatment with rTMS or electroconvulsive therapy (ECT); any past treatment with deep brain stimulation or vagus nerve stimulation;
- Have an active suicidal intent or plan, or in the opinion of the investigator, is likely to attempt suicide in the next 6 months;
- Presence of condition or circumstance with potential to prevent study completion;
- Inability to obtain sufficient EEG to calibrate study device.
Where it is running
- Providence VAMC — Providence, Rhode Island, United States
- White River Junction VAMC — White River Junction, Vermont, United States
Full record on ClinicalTrials.gov
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