Transcranial Magnetic Stimulation in Veterans With PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-70
SponsorWhite River Junction Veterans Affairs Medical Center
About this trial
With this research investigators hope to begin to understand how rTMS can improve posttraumatic stress disorder (PTSD) symptoms. TMS improves PTSD through two interrelated mechanisms: change in brain limbic system function and change in systemic inflammatory activation. Participants who decide to join this study, will receive ten rTMS treatments. All participants will undergo a 40-minute rTMS procedure with a member of the study team 10 times over 2-4 weeks. Participants will undergo fMRI scans of the head in order to help researchers better understand potential effects of rTMS on brain activity. In addition, participants will be asked to give two breath and blood samples to look for signs of general inflammation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 19 and 70
Eligible for VA healthcare
Moderate to severe PTSD as determined by a total score of at least 25 on the CAPS within 7 days of randomization.
Agree to have CAPS audio recorded.
Disqualifiers
Pregnant or lactating woman.
MRI is contraindicated
Current use of clozapine (any dose) or bupropion (more than 300mg per day).
Cardiac pacemaker or implantable defibrillator.
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Magnetic Stimulation
Device10 sessions of low frequency rTMS (1Hz) applied to the right dorsolateral prefrontal cortex.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Participants receiving open label trial of TMSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency and intensity of PTSD symptoms as assessed by the CAPS-5
The CAPS is a clinician-administered scale of PTSD symptoms, which queries the frequency and intensity of symptoms of PTSD
Time frame
From enrollment to the end of treatment at 3 months2
20 item self-report of PTSD symptoms assessed by PCL-5
It asks participants to rate the severity of each of the 20 symptoms of PTSD in DSM-5
Time frame
From enrollment to the end of treatment at 3 monthsSecondary outcomes
1
A quick self-reported and self administered inventory of depressive symptoms (QIDS-16-SR)
This is a self-reported, self- administered scale of depressive symptoms.
Time frame
From the baseline to the end of the study at 3 monthsSponsors and contacts
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Source ClinicalTrials.gov