MAGNETS is a prospective, randomized, parallel-design, sham-controlled clinical trial of accelerated, functional magnetic resonance imaging (fMRI)-guided intermittent theta burst stimulation (iTBS) to the right dorsolateral prefrontal cortex (dlPFC) for chronic symptoms of posttraumatic stress disorder (PTSD) in a comorbid Veteran population.
In MAGNETS, sixty-four participants will be recruited from the NMVAHCS PTSD programs, Polytrauma services, and outpatient mental health clinics. At study entry (Visit #1), participants will undergo baseline demographic, behavioral, and cognitive assessment, and fMRI and diffusion tensor imaging (DTI). The data analysis team will then determine the image-based target in the right hemisphere. Participants will be randomized to either the active (n=32) or sham (n=32) group and undergo 50 sessions of iTBS (10x/day, five days). At end of treatment (Visit #2), they will repeat all baseline tests, including fMRI. One-, three- and six-month symptom levels will be obtained through phone visits (Visits #3-5) to establish longevity and stability of benefit. Repeated measures analyses will be performed on behavioral and connectivity variables, with clinical (age, duration, head injury history) and imaging (white matter fiber counts) features as covariates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Intermittent theta burst stimulation (iTBS) is an efficient form of transcranial magnetic stimulation that allows up to 10x more pulses to be delivered in a given timeframe compared to conventional stimulation patterns.
Intermittent theta burst stimulation (iTBS) is an efficient form of transcranial magnetic stimulation that allows up to 10x more pulses to be delivered in a given timeframe compared to conventional stimulation patterns.
UNM Center for Psychiatric Research
Albuquerque, New Mexico, United States
RECRUITINGNew Mexico VA Health Care System
Albuquerque, New Mexico, United States
RECRUITINGCAPS-5
Clinician Administered PTSD Scale-DSM 5 (range 0-80; higher scores = more symptoms)
Time frame: Immediate post-treatment visit
PCL-5
PTSD Checklist-DSM 5 (range 0-80; higher scores = more symptoms)
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
PHQ-9
Patient Health Questionnaire-9 (range 0-27; higher scores = more symptoms)
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
GAD-7
Generalized Anxiety Disorder-7 (range 0-21; higher scores = more symptoms)
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
NSI
Neurobehavioral Symptom Inventory (range 0-88; higher scores = more symptoms)
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
DSM-XC (range 0-92; higher scores = more symptoms)
Diagnostic and Statistical Manual Cross-Cutting Assessment
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
WHODAS
World Health Organization Disability Assessment Schedule (range 0-100; higher scores = more disability)
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
PGIC
Patient Global Impression of Change (range 0-7; higher scores = more positive change)
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Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months