Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for Treatment of Post-Traumatic Stress Disorder (PTSD)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transcranial Magnetic Stimulation
  Personalized 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.
• Устройство Transcranial Magnetic Stimulation Sham
  Sham 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) applie

Первичные конечные точки

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Срок оценки: At baseline and the end of treatment at Week 6.]

Вторичные конечные точки (12)

• Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Срок оценки: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.]
• Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.]
• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.]
• Tinnitus Functional Index (TFI) [Срок оценки: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.]
• TMS Tolerability Worksheet (TTW) [Срок оценки: At baseline and weekly during Weeks 1-6.]
• Pittsburgh Sleep Quality Index Addendum (PSQI-A) [Срок оценки: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.]
• Total Sleep Time (Oura Ring) [Срок оценки: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.]
• Sleep Efficiency (Oura Ring) [Срок оценки: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.]
• Sleep Latency (Oura Ring) [Срок оценки: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.]
• REM Sleep Duration (Oura Ring) [Срок оценки: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.]
• REM Sleep Percentage (Oura Ring) [Срок оценки: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.]
• Light Sleep Duration (Oura Ring) [Срок оценки: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Home Base — Charlestown

Публикации

• Makale MT, Nybo C, Blum K, Dennen CA, Elman I, Murphy KT. Pilot Study of Personalized Transcranial Magnetic Stimulation with Spectral Electroencephalogram Analyses for Assessing and Treating Persons with Autism. J Pers Med. 2024 Aug 12;14(8):857. doi: 10.3390/jpm14080857. PMID 39202048
• Makale MT, Nybo C, Keifer J, Blum K, Dennen CA, Baron D, Sunder K, Elman I, Makale MR, Thanos PK, Murphy KT. Preliminary Observations of Personalized Repetitive Magnetic Stimulation (PrTMS) Guided by EEG Spectra for Concussion. Brain Sci. 2023 Aug 9;13(8):1179. doi: 10.3390/brainsci13081179. PMID 37626535
• Makale MT, Abbasi S, Nybo C, Keifer J, Christman L, Fairchild JK, Yesavage J, Blum K, Gold MS, Baron D, Cadet JL, Elman I, Dennen CA, Murphy KT. Personalized repetitive transcranial magnetic stimulation (prtms(R)) for post-traumatic stress disorder (ptsd) in military combat veterans. Heliyon. 2023 Aug 8;9(8):e18943. doi: 10.1016/j.heliyon.2023.e18943. eCollection 2023 Aug. PMID 37609394

Идентификаторы

NCT: NCT07526285 · 2025P003206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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