Targeted Accelerated TMS for Post-Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital
About this trial
Post-traumatic stress disorder (PTSD) is a highly prevalent and debilitating condition among veterans and active-duty military personnel, with rates as high as 30% in certain combat-exposed populations. Conventional treatments such as prolonged exposure therapy and pharmacotherapy have limited efficacy and high dropout rates, highlighting the need for novel, rapidly effective interventions.
Transcranial magnetic stimulation (TMS) has been well established for treatment-resistant depression (TRD). Traditional TMS, which involves 6 to 7 weeks of daily, weekday scalp-targeted treatment, shows open-label response and remission rates of 58.1% and 30%, respectively. However, such protocols may be impractical for military personnel with limited medical leave. A new form of accelerated TMS (aTMS) that involves 10 imaging-guided treatments per day for 5 consecutive days has demonstrated substantial antidepressant benefits within days and response rates of 69% at 1-month follow-up. This protocol has not been tested for PTSD, in part because there was no causally informed brain circuit target. In this study, the investigators will test aTMS for PTSD using a novel PTSD circuit that the investigators have derived.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65
DSM-5 diagnosis of PTSD per PTSD Checklist for DSM-5 (CAPS-5)
At least moderate symptoms of PTSD per PCL-5 (≥21)
English proficiency sufficient to understand risks/benefits
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial Magnetic Stimulation
Procedure/SurgeryTranscranial magnetic stimulation (TMS) is a focal, non-invasive form of brain stimulation that has FDA clearance for depression. In this study, a form of TMS called accelerated intermittent theta burst stimulation (aiTBS) will be administered under the supervision of a physician with TMS expertise.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active aiTBSActive comparator 1 intervention
Group B: Sham aiTBSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
PTSD Checklist with Criterion A for DSM-5 (PCL-5)
20 item PTSD scale, scored 0-80. Higher scores indicate worse symptoms. Investigators will use a repeated measures mixed model to examine the effect of treatment on PCL-5 scores over time as well as a group x time interaction not controlling for depression. Hypothesis: There will be a significant difference in PCL-5 score magnitude of change one month after treatment relative to baseline in the participants receiving active treatment vs. sham
Time frame
Before treatment to 1-month post treatmentSecondary outcomes
1
PTSD Checklist with Criterion A for DSM-5 (PCL-5)
20 item PTSD scale, scored 0-80. Higher scores indicate worse symptoms. Investigators will determine between-group effect size based on the change in PCL-5 score one month after treatment. Hypothesis: Relative to sham aTMS, active aTMS will show a moderate-to-large effect size.
Time frame
Before treatment to 1-month post treatmentOther outcomes
1
Clinician-Administered PTSD Scale for DSM-5 (CAP-5)
30-item clinical interview designed to assess PTSD based on DSM-5 criteria. Total scores from 0-80, with higher numbers indicating greater PTSD symptom severity.
Time frame
Before treatment and 1 month after treatment2
Beck Depression Inventory (BDI)
Depression severity rating scales (0-63, higher numbers indicate higher severity)
Time frame
Before treatment, 1 week post treatment, and 1 month post treatment3
Beck Anxiety Inventory (BAI)
Anxiety severity rating scale (0-63, higher numbers indicate higher severity)
Time frame
Before treatment, 1 week post treatment, and 1 month post treatment4
Young Mania Rating Scale (YMRS)
11 item scale evaluating mania. Scored 0-60. Higher score indicates worse outcome/higher mania
Time frame
Before treatment, daily for 5 treatment days, and 1 month post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Mass General Home Base Program
Collaborator
Source ClinicalTrials.gov