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NCT07526285

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

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 10 months later.

See at-risk trials from Massachusetts General Hospital

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 31, 2028 to May 31, 2029 Show 5 more changesShow less
    • Start date: Aug 1, 2026 to Jun 1, 2027
    • Eligibility criteria expanded, about 17 words
    • Study completion pushed from Jan 31, 2029 to Dec 31, 2029
    • Secondary endpoints: details revised at 8 of 25 entries
    • Publications: details revised at 3 of 3 entries
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Timeframe: At baseline and the end of treatment at Week 6.

Secondary (25)

Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Generalized Anxiety Disorder-7 (GAD-7)
Patient Health Questionnaire-9 (PHQ-9)
Tinnitus Functional Index (TFI)
TMS Tolerability Worksheet (TTW)
Show 20 moreShow less
Pittsburgh Sleep Quality Index Addendum (PSQI-A)
Total Sleep Time (Oura Ring)
Sleep Efficiency (Oura Ring)
Sleep Latency (Oura Ring)
REM Sleep Duration (Oura Ring)
REM Sleep Percentage (Oura Ring)
Light Sleep Duration (Oura Ring)
Light Sleep Percentage (Oura Ring)
Deep Sleep Duration (Oura Ring)
Deep Sleep Percentage (Oura Ring)
Resting Heart Rate (Oura Ring)
Heart Rate Variability (Oura Ring)
Body Temperature (Oura Ring)
Daily Step Count (Oura Ring)
Active Energy Expenditure (Oura Ring)
Total Energy Expenditure (Oura Ring)
Sedentary Activity Duration (Oura Ring)
Light Activity Duration (Oura Ring)
Moderate Activity Duration (Oura Ring)
Vigorous Activity Duration (Oura Ring)

Arms and interventions

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.

Sham PrTMSSham 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.

Devices: Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation Sham

Sites

1 site in 1 country

  • Home BaseCharlestown, Massachusetts, United States