Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for Treatment of Post-Traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
研究概览
简要总结
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.
详细描述
This study is a randomized, double-blind, sham-controlled trial evaluating a personalized approach to repetitive transcranial magnetic stimulation (PrTMS) for the treatment of post-traumatic stress disorder (PTSD) in military service members and veterans. PrTMS integrates spectral electroencephalography (sEEG) with neurocognitive assessments to individualize stimulation parameters, including frequency and intensity, and to allow for dynamic adjustment over the course of treatment based on each participant's evolving neurophysiological profile. Participants will undergo a 6-week treatment protocol (5 sessions per week), followed by longitudinal assessments over 6 months to evaluate durability of response. Multimodal outcomes will include clinician-administered and self-report measures of PTSD, mood, anxiety, and sleep, as well as physiologic and behavioral data collected via wearable devices. This study is designed to determine whether EEG-guided, precision neuromodulation improves clinical outcomes compared to standard, non-personalized stimulation approaches and to inform the development of individualized treatment strategies in PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
In addition to the masked participants and care providers, the study statistician and collaborating investigators at the United States Air Force Research Laboratory (AFRL) will also remain blinded to treatment allocation. All data shared with these parties will be coded and de-identified, with treatment groups labeled in a manner that prevents identification of active versus sham conditions until completion of the primary analysis or unless unblinding is required for safety reasons.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Proficient in English (spoken and written) to ensure understanding of study procedures and informed consent
排除标准
- •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
- •Repetitive transcranial magnetic stimulation (rTMS) within 3 months prior to screening
- •Current use of antipsychotic or anticonvulsant medications
- •Presence of intracranial implants or non-removable metal in or near the head (excluding the mouth)
- •Clinically significant or unstable medical conditions, including active suicidal ideation
- •Uncontrolled medical illness (e.g., thyroid, hepatic, cardiac, pulmonary, or renal disease)
- •Initiation of PTSD-specific treatment within the past 4 weeks (participants on a stable regimen may be eligible)
- •Pregnancy (for women of childbearing potential)
- •Any condition that, in the opinion of the investigator, may interfere with study participation or completion
研究组 & 干预措施
Active PrTMS (EEG-Guided rTMS)
Participants receive personalized, EEG-guided repetitive transcranial magnetic stimulation (PrTMS) administered 5 days per week for 6 weeks, with stimulation parameters individualized and adjusted over time based on serial sEEG and neurocognitive assessments.
干预措施: Transcranial Magnetic Stimulation (Device)
Sham PrTMS
Participants receive sham repetitive transcranial magnetic stimulation (rTMS) administered 5 days per week for 6 weeks using a sham coil that mimics the sound and sensation of active treatment without delivering a therapeutic magnetic field.
干预措施: Transcranial Magnetic Stimulation Sham (Device)
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: At baseline and the end of treatment at Week 6.
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.
次要结局
- REM Sleep Duration (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- REM Sleep Percentage (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)(At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.)
- Generalized Anxiety Disorder-7 (GAD-7)(At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.)
- Patient Health Questionnaire-9 (PHQ-9)(At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.)
- Tinnitus Functional Index (TFI)(At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.)
- Light Sleep Duration (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- TMS Tolerability Worksheet (TTW)(At baseline and weekly during Weeks 1-6.)
- Pittsburgh Sleep Quality Index Addendum (PSQI-A)(At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.)
- Total Sleep Time (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Sleep Efficiency (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Sleep Latency (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Light Sleep Percentage (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Deep Sleep Duration (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Deep Sleep Percentage (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Resting Heart Rate (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Heart Rate Variability (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Body Temperature (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Daily Step Count (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Active Energy Expenditure (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Total Energy Expenditure (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Sedentary Activity Duration (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Light Activity Duration (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Moderate Activity Duration (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
- Vigorous Activity Duration (Oura Ring)(Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.)
研究者
Sofia Matta
Director
Massachusetts General Hospital