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Behavioural Intervention
TMS for PTSD (rTMS for PTSD Trial)
N/A
Recruiting
Led By Bradley V Watts, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 19 and 70
Be older than 18 years old
Must not have
Significant central nervous system disorder (stroke, brain mass, epilepsy)
Prior use of TMS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Summary
This trial is testing whether transcranial magnetic stimulation, a treatment for depression, is also effective for treating PTSD in veterans.
Who is the study for?
This trial is for Veterans aged 19-70 with moderate to severe PTSD, eligible for VA healthcare. Participants must not be using certain medications like high-dose bupropion or clozapine, have no metal in their head (except dental work), no major CNS disorders, unstable medical conditions, recent seizures, or current psychosis. Women of childbearing potential must use birth control.
What is being tested?
The study tests if Transcranial Magnetic Stimulation (TMS), a non-invasive method using magnets to stimulate the brain, can improve functioning in Veterans with PTSD compared to sham TMS. It's randomized and involves 91 participants who either receive real TMS or a placebo-like sham treatment.
What are the potential side effects?
While the description doesn't specify side effects of TMS, common ones include headache, scalp discomfort at the stimulation site during treatment sessions, lightheadedness and rare risk of seizure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 19 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a major brain condition like a stroke, tumor, or epilepsy.
Select...
I have previously used TMS therapy.
Select...
I am currently taking clozapine or more than 300mg of bupropion daily.
Select...
I have undergone PTSD therapy using CPT or PE in the last 2 months.
Select...
I have had a seizure in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CAPS
QIDS SR-16
WHODAS
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TMSExperimental Treatment1 Intervention
transcranial magnetic stimulation delivered to the right dorsolateral prefrontal cortex at 1 Hz
Group II: ShamPlacebo Group1 Intervention
sham transcranial magnetic stimulation delivered to the right dorsolateral prefrontal cortex
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,575 Total Patients Enrolled
Bradley V Watts, MD MPHPrincipal InvestigatorWhite River Junction VA Medical Center, White River Junction, VT
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a major brain condition like a stroke, tumor, or epilepsy.You are eligible for VA healthcare.You have a problem with alcohol or drugs that affects your ability to take part in the study.I am between 19 and 70 years old.I have previously used TMS therapy.I am currently taking clozapine or more than 300mg of bupropion daily.I have undergone PTSD therapy using CPT or PE in the last 2 months.You are able to obtain a Motor Threshold using the TMS device during screening.I have had a seizure in the last year.You frequently think about hurting yourself or ending your life.You have a device in your heart called a pacemaker or implantable defibrillator.If female with childbearing potential, use of acceptable method of birth control (i.e., use of contraceptives, abstinence).You have agreed to have your voice recorded for the purpose of being heard by a clinician.You have moderate to severe PTSD.I haven't changed my depression medication in the last 2 months.You are currently experiencing extreme mood swings or hallucinations.
Research Study Groups:
This trial has the following groups:- Group 1: TMS
- Group 2: Sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.