This study is testing a personalized form of brain stimulation called PrTMS as a treatment for post-traumatic stress disorder (PTSD) in military service members and veterans. Unlike standard approaches, this treatment uses a simple brainwave test (EEG) to tailor the therapy to each individual. Participants will be randomly assigned to receive either active treatment or a comparison (sham) treatment over 6 weeks. Researchers will track changes in PTSD symptoms, mood, sleep, and overall well-being, including using wearable devices to measure things like sleep and heart rate. The goal is to see whether this personalized approach can provide greater and longer-lasting relief for individuals living with PTSD.
Reserve or former member of the military (veteran status)
Age 18 years or older
Primary diagnosis of post-traumatic stress disorder (PTSD) confirmed by the - Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) score ≥ 33, indicating clinically significant PTSD symptoms
History of open-skull traumatic brain injury
Clinically significant seizure disorder or history of manic episodes
Neurological conditions associated with increased risk (e.g., increased intracranial pressure, brain lesions, stroke, cerebral aneurysm)
Electroencephalogram (EEG) abnormalities suggesting elevated seizure risk
Parallel
Transcranial Magnetic Stimulation
DevicePersonalized repetitive transcranial magnetic stimulation (PrTMS) is delivered using the Neurocare Apollo TMS Therapy System for 30 minutes per session, 5 days per week, over 6 weeks. Stimulation parameters (frequency 8-13 Hz and intensity typically 50-60% of motor threshold) are individualized based on baseline and serial spectral EEG (sEEG) assessments, with adjustments made throughout treatment to optimize response.
Transcranial Magnetic Stimulation Sham
DeviceSham stimulation will be delivered using the same Neurocare Apollo TMS Therapy System as the active intervention, with identical treatment schedule (5 days per week for 6 weeks; 30 minutes per session). A sham coil identical in appearance to the active coil will be used, which does not generate a therapeutic magnetic field. To mimic the sensory experience of active treatment, the sham procedure will produce similar auditory clicking and will include a surface electrical stimulation (TENS) applied to the forehead to replicate scalp sensations and mild muscle contraction. This approach is designed to maintain blinding while delivering no active neuromodulatory effect.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured interview and gold standard for diagnosing and assessing PTSD in clinical and research settings. It assesses current or lifetime PTSD based on DSM-5 criteria and measures symptom severity across the 20 PTSD symptoms, including the dissociative subtype, in relation to a single index traumatic event. Total severity scores range from 0 to 80, with higher scores indicating worse PTSD symptom severity.
Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
The Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses PTSD symptom presence and severity across DSM-5 symptom clusters, including re-experiencing, avoidance, negative alterations in cognition and mood, and arousal. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item self-report scale used to assess the severity of generalized anxiety symptoms and to screen for anxiety over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure used to screen, diagnose, monitor, and assess the severity of depression. Total scores range from 0 to 27, with higher scores indicating greater depression severity.
Tinnitus Functional Index (TFI)
The Tinnitus Functional Index (TFI) is a 25-item self-report questionnaire designed to measure the severity, negative impact, and treatment-related changes of tinnitus on a person's daily life over the past week. Total scores range from 0 to 100, with higher scores indicating greater tinnitus severity and functional impact.
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Massachusetts General Hospital
Lead sponsor
United States Air Force Research Laboratory
Collaborator
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