ONE-P TMS Military Veterans

Sponsor
Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA
Study ID
NCT07777380
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex
ALL
Age
19 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • D-Cycloserine (DCS) — DRUG
    Participants randomized to the active treatment arm will receive DCS 125 mg orally, administered as one capsule around one hour before active aiTBS treatment.
  • Placebo — 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.
  • Intermittent Theta Burst Stimulation (iTBS) — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: active aiTBS plus DCS
  • Placebo Comparator: active aiTBS plus placebo DCS

Primary Outcome Measure

Feasibility of one-day iTBS+DCS: Enrolment [ Time Frame: 1.5 years ]

Central Contacts

Related Studies