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.
are aged 18-80;
have a documented diagnosis of PTSD with evidence of ongoing symptoms as demonstrated by score of "31" or higher on the PCL-5, a measure of posttraumatic stress symptoms;
are fluent in English (as the neuropsychological testing tools used are only available in English) and
have been on stable doses of psychotropic medications for the past month.
a prior history of other neurological disease beyond mild TBI, as determined by VA/DoD criteria for TBI severity;
any history of seizures beyond immediate posttraumatic seizure or childhood febrile seizure, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
history of a psychotic disorder, such as schizophrenia or bipolar disorder, so as to reduce risk of psychiatric decompensation;
active substance/alcohol dependence without ongoing treatment, to reduce confounding effects on diagnosis and brain imaging;
Parallel
Active Intermittent theta burst stimulation
DeviceIntermittent 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.
Sham Intermittent theta burst stimulation
DeviceIntermittent 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.
CAPS-5
Clinician Administered PTSD Scale-DSM 5 (range 0-80; higher scores = more symptoms)
PCL-5
PTSD Checklist-DSM 5 (range 0-80; higher scores = more symptoms)
PHQ-9
Patient Health Questionnaire-9 (range 0-27; higher scores = more symptoms)
GAD-7
Generalized Anxiety Disorder-7 (range 0-21; higher scores = more symptoms)
NSI
Neurobehavioral Symptom Inventory (range 0-88; higher scores = more symptoms)
AIM
Acceptability of Intervention Measure, a four-item measure of the acceptability of an intervention. It has five questions, scored on a 5-point Likert scale, from "completely disagree" to "completely agree"
fMRI Connectivity
Connectivity between the dlPFC and vmPFC (range -1.0 to 1.0; higher scores indicate greater degree of positive correlation
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University of New Mexico
Lead sponsor
New Mexico VA Healthcare System
Collaborator
