Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days
ConditionPTSD
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVA Office of Research and Development
About this trial
Veterans with posttraumatic stress disorder (PTSD) need more effective treatments. Existing options can have limited adherence and can be very time-consuming. As such, alternative interventions are needed. Transcranial magnetic stimulation (TMS) has been FDA-cleared for depression since 2008 and has recently been cleared to treat smoking cessation and obsessive-compulsive disorder. It has demonstrated promise for reducing PTSD symptom severity but standard TMS has a significant time requirement. This study will compare an accelerated 5-day form of TMS versus sham for PTSD, characterizing efficacy and durability. This project will provide important information that can be implemented in the near term for Veterans with PTSD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of chronic post-traumatic stress disorder (PTSD), meeting DSM-5 criteria
Eligible Veterans
Symptomatic despite ongoing stable treatment (medications, psychotherapy, etc.) for at least 6 weeks before study procedures
Ongoing medications and psychotherapy will be allowed to continue unchanged during the study
Disqualifiers
Primary psychotic disorder, bipolar I disorder, and greater than moderate substance use disorder (within the last month, excluding nicotine/caffeine, assessed by a urine drug screen as indicated), determined by the Mini International Neuropsychiatric Interview (MINI)
Active suicidal intent or plan, as detected on screening instruments or in the investigator team's opinion, is likely to attempt suicide within 6 months
The presence of any other condition or circumstance that, in the opinion of the investigator team, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
History of neurological disorder (e.g., multiple sclerosis, seizure disorder, etc.) or systemic illness affecting central nervous system (CNS) function (e.g., liver failure, kidney failure, congestive heart failure, metastatic cancer) or that could meaningfully impact cortical excitability
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial magnetic stimulation
DeviceiTBS; 50 hertz (Hz) triplets given at 5 Hz frequency with a cycle time of 2 seconds on and 8 seconds off). There will be 60 cycles for a total of 1800 pulses
Sham transcranial magnetic stimulation
DeviceSham iTBS; 50 hertz (Hz) triplets given at 5 Hz frequency with a cycle time of 2 seconds on and 8 seconds off). There will be 60 cycles for a total of 1800 pulses
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Active TMSActive comparator 1 intervention
Group B: Sham TMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-traumatic stress disorder (PTSD) Checklist for the DSM-5
Measure of the number and severity of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate more severe PTSD.
Time frame
T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatmentSecondary outcomes
1
Executive Functioning
A set of several neuropsychological measures used to assess executive functioning skills. Administered measures will be transformed into standard scores in order to compare across various measures and create an overall aggregate score. Range will be -2.50 to 2.50 where higher scores indicate better functioning.
Time frame
T1: Baseline, T2: Post-Treatment, & T4 3 months post treatment2
Pittsburgh Sleep Quality Index
Measure of sleep disturbance and sleep quality. Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with where lower scores denote a healthier sleep quality.
Time frame
T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment3
Short-Form-36
Measure of quality of life consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Time frame
T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: