Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
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About
The purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.
Full description
Using three treatment arms, the study will examine Posttraumatic Stress Disorder (PTSD) symptom reduction when (1) 1 Hz (hertz) repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) is administered prior to each of 12 Cognitive Processing Therapy (CPT) sessions compared to when (2) sham rTMS is administered to the rDLPFC is administered prior to each of 12 CPT sessions and to when (3) 1 Hz rTMS is delivered to rDLPFC alone over 12 sessions.
Veterans with combat-related PTSD will be randomly assigned to one of the three treatment arms. Primary outcome PTSD symptom severity measures, secondary neuropsychological, electroencephalography (EEG), and magnetic resonance imaging (MRI) outcome measures, and prescreening assessments for study contraindicators will be collected prior to being assigned to a treatment arm (i.e., baseline).
Primary outcome PTSD symptom severity measures and secondary neuropsychological outcome measures will be collected twice within the span of the treatment sessions (i.e., sessions 5 and 9) and at three times following treatment competition (i.e., 1-month, 6-months, and 12-months). EEG also will be collected at the 1-month, 6-month, and 12-month assessments, and MRI will be collected at the 6-month and 12-month assessments.
Enrollment
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Inclusion criteria
- Veterans of Post-9/11 military conflicts
- with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat
Exclusion criteria
- current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment
- PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation
- history of epilepsy or seizure disorder, a history of major head trauma,
- any neurologic condition likely to increase risk of seizures,
- brain tumors,
- moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment
- stroke, and blood vessel abnormalities in the brain,
- dementia,
- Parkinson's disease, Huntington's chorea, or multiple sclerosis
- a high suicide risk
- a lifetime history of psychotic disorder or bipolar disorder
- inability to stop taking any medication that significantly lowers the seizure threshold
- pregnant or nursing
- metal fragments in the head, or any metal objects in or near the head that cannot be safely removed
- We will screen for a history of traumatic brain injury and exclude potential participants from the study if they have a history of severe TBI or are at high risk for seizures.
- history of seizures
- non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except for English
- cardiac pacemaker, implanted medication pumps of any sort that would increase the risk of rTMS
- any current medical condition that could preclude being able to safely participate in TMS treatment,
- use of prescription medication or illegal substances that lower the seizure threshold
- previous rTMS
Trial design
Primary purpose
Allocation
Interventional model
Masking
330 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Jill Ritter, BS; Elizabeth "Ellen" Morris, PhD
Data sourced from clinicaltrials.gov
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