ONE-P TMS Military Veterans
NCT07777380 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-08-20
Summary
The aim of this study is to examine the feasibility and tolerability of a one-day protocol of repetitive transcranial magnetic stimulation with D-cycloserine (DCS) as an augmentation strategy in military personnel and veterans who have PTSD.
Conditions
- PTSD - Post Traumatic Stress Disorder
Interventions
- DRUG
-
D-Cycloserine (DCS)
Participants randomized to the active treatment arm will receive DCS 125 mg orally, administered as one capsule around one hour before active aiTBS treatment.
- DRUG
-
Participants randomized to the placebo arm will receive one matched placebo capsule administered orally at the same time point and according to the same procedures as the active investigational product.
- DEVICE
-
Intermittent Theta Burst Stimulation (iTBS)
rTMS will employ the MagPro X100/R30 stimulator (MagVenture, Farum, Denmark) equipped with the B70 coil. A scalp heuristic will be used to localize the treatment site over the right DLPFC by modifying the BeamF3 method to the contralateral side. We have previously reported good congruency between the BeamF3 heuristic method and MRI-guided neuronavigation. Prior to the first treatment, each subject's resting motor threshold (RMT) will first be determined according to published methods. Patients will receive 3 minutes of iTBS every 30 minutes for a total of 15 session over two separate days three weeks apart day of treatment using the following parameters: 50 Hz triplet bursts, 5 bursts per second, 2 s on and 8 s off for 20 trains of 600 pulses, preceded by an introductory 3-train acclimatization titration, at an intensity of 80% of the RMT. The treatment protocol will be repeated 3 weeks after the initial treatment day.
Sponsors & Collaborators
-
Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA
lead OTHER
Principal Investigators
-
Fidel Vila-Rodriguez, M.D., PhD, FRCPC, DFAPA · University of British Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-11-01
- Primary Completion
- 2028-06-01
- Completion
- 2029-01-01
Countries
- Canada
Study Locations
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