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ONE-P TMS First Responders

NCT07773935 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-19

No results posted yet for this study

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 first responders 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

Placebo

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773935 on ClinicalTrials.gov