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| Name | Class |
|---|---|
| United States Air Force Research Laboratory | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active PrTMS (EEG-Guided rTMS) | Active Comparator | 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. |
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| Sham PrTMS | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and the end of treatment at Week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Bonvie, PsyD | Contact | 8572053407 | jbonvie@mgh.harvard.edu | |
| Alan Berkeley, MBA | Contact | 8572839928 | aberkeley@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sofia E Matta, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Home Base | Charlestown | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39202048 | Background | 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. | |
| 37626535 | Background | 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. |
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Individual participant data (IPD) will not be shared. Only de-identified, aggregate data may be shared with collaborators, including the United States Air Force Research Laboratory (USAFRL), under a data sharing agreement.
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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.
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| Transcranial Magnetic Stimulation Sham | Device | 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) 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. |
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| At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34. |
| 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. | At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34. |
| 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. | At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34. |
| 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. | At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34. |
| TMS Tolerability Worksheet (TTW) | The TMS Tolerability Worksheet (TTW) is a clinician-administered tool used to document session-related side effects and adverse events associated with transcranial magnetic stimulation (TMS), including symptoms such as headache, neck pain, discomfort at the stimulation site, and hearing changes, with severity categorized as none, mild, moderate, or severe. | At baseline and weekly during Weeks 1-6. |
| Pittsburgh Sleep Quality Index Addendum (PSQI-A) | The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) is a self-report measure that assesses disruptive nocturnal behaviors associated with PTSD, including nightmares, panic, hot flashes, and acting out dreams. Total scores range from 0 to 21, with higher scores indicating greater severity of disruptive nocturnal behaviors. | At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34. |
| Total Sleep Time (Oura Ring) | Total sleep time, measured in hours per night using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Sleep Efficiency (Oura Ring) | Sleep efficiency, expressed as a percentage (0-100%) representing the ratio of time spent asleep relative to the total time in bed, using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Sleep Latency (Oura Ring) | Sleep latency, measured in minutes, defined as the time from the start of the sleep period to sleep onset, as recorded by the Oura Ring wearable device. Typical values range from approximately 0 to 60 minutes. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| REM Sleep Duration (Oura Ring) | Duration of rapid eye movement (REM) sleep, measured in minutes using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| REM Sleep Percentage (Oura Ring) | REM sleep expressed as a percentage of total sleep time, measured using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Light Sleep Duration (Oura Ring) | Duration of light sleep, measured in minutes using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Light Sleep Percentage (Oura Ring) | Light sleep expressed as a percentage of total sleep time, measured using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Deep Sleep Duration (Oura Ring) | Duration of deep (slow-wave) sleep, measured in minutes using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Deep Sleep Percentage (Oura Ring) | Deep (slow-wave) sleep expressed as a percentage of total sleep time, measured using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Resting Heart Rate (Oura Ring) | Resting heart rate, measured in beats per minute (bpm) using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Heart Rate Variability (Oura Ring) | Heart rate variability (HRV), measured in milliseconds (ms) using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Body Temperature (Oura Ring) | Nightly body temperature deviation from baseline, measured in degrees Fahrenheit (°F) using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Daily Step Count (Oura Ring) | Daily step count, measured as the number of steps per day using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Active Energy Expenditure (Oura Ring) | Active energy expenditure, measured in kilocalories per day (kcal/day) using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Total Energy Expenditure (Oura Ring) | Total energy expenditure, measured in kilocalories per day (kcal/day) using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Sedentary Activity Duration (Oura Ring) | Duration of sedentary activity, measured in minutes per day using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Light Activity Duration (Oura Ring) | Duration of light physical activity, measured in minutes per day using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Moderate Activity Duration (Oura Ring) | Duration of moderate physical activity, measured in minutes per day using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| Vigorous Activity Duration (Oura Ring) | Duration of vigorous physical activity, measured in minutes per day using the Oura Ring wearable device. | Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34. |
| 37609394 | Background | 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. |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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