Posttraumatic Stress Disorder (PTSD)NCT07526285
Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for Treatment of Post-Traumatic Stress Disorder (PTSD)
A study testing Transcranial Magnetic Stimulation in people with Posttraumatic Stress Disorder (PTSD), run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Home Base
Charlestown, Massachusetts, 02129
Alan Berkeley, MBA, 8572839928, aberkeley@mgh.harvard.edu
Sofia E Matta, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation Sham
- Keywords
- Transcranial Magnetic Stimulation, Posttraumatic Stress Disorder, Veterans, Precision Medicine
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
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.
Transcranial Magnetic Stimulation ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Magnetic Stimulation |
| 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. Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and the end of treatment at Week 6.
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Air Force Research Laboratory
- Responsible party
- Principal investigator, Sofia Matta, Massachusetts General Hospital
- Investigators
- Sofia E Matta, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526285
- Sponsor's protocol ID
- 2025P003206
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39202048Makale 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.
PubMed 37626535Makale 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.
PubMed 37609394
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for Treatment of Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT07526285
- Acronym / sponsor ID
- 2025P003206
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Transcranial Magnetic Stimulation, Posttraumatic Stress Disorder, Veterans, Precision Medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Air Force Research Laboratory
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PrTMS (EEG-Guided rTMS) | Active comparator | Device: Transcranial Magnetic StimulationParticipants 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. |
| Sham PrTMS | Sham comparator | Device: Transcranial Magnetic Stimulation ShamParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationPersonalized 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. | Device | Active PrTMS (EEG-Guided rTMS) |
| Transcranial Magnetic Stimulation ShamSham 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. | Device | Sham PrTMS |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: 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.
25 secondary outcomes
Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.
Tinnitus Functional Index (TFI)
Time frame: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.
TMS Tolerability Worksheet (TTW)
Time frame: At baseline and weekly during Weeks 1-6.
Pittsburgh Sleep Quality Index Addendum (PSQI-A)
Time frame: At baseline, and weekly during Weeks 1-6, and at Week 10, Week 22, and Week 34.
Total Sleep Time (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Sleep Efficiency (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Sleep Latency (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
REM Sleep Duration (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
REM Sleep Percentage (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Light Sleep Duration (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Light Sleep Percentage (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Deep Sleep Duration (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Deep Sleep Percentage (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Resting Heart Rate (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Heart Rate Variability (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Body Temperature (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Daily Step Count (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Active Energy Expenditure (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Total Energy Expenditure (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Sedentary Activity Duration (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Light Activity Duration (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Moderate Activity Duration (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Vigorous Activity Duration (Oura Ring)
Time frame: Continuously from enrollment through Week 6, and at follow-up at Week 10, Week 22, and Week 34.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 39202048Makale 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.
- Background: PubMed 37626535Makale 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.
- Background: PubMed 37609394Makale 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sofia E Matta, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Posttraumatic Stress Disorder (PTSD), run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Bonvie, PsyD (8572053407, jbonvie@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: At baseline and the end of treatment at Week 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07526285, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.