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

NCT07526285 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025P003206
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Transcranial Magnetic Stimulation; Posttraumatic Stress Disorder; Veterans; Precision Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (25)

• 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.

• TMS Tolerability Worksheet (TTW)

  At baseline and weekly during Weeks 1-6.

Study Arms (2)

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.

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.

Device: Transcranial Magnetic Stimulation Sham

Interventions

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.

Active PrTMS (EEG-Guided rTMS)

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.

Sham PrTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• United States Air Force Research Laboratory: collaborator

Study Sites (1)

Home Base

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (3)

• 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 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.

  PMID: 37626535 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.

  PMID: 37609394 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Sofia E Matta, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Bonvie, PsyD

CONTACT

8572053407; jbonvie@mgh.harvard.edu

Alan Berkeley, MBA

CONTACT

8572839928; aberkeley@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)