ONE-P TMS First Responders

NCT07773935 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: H25-03191
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transcranial Magnetic Stimulation; iTBS; PTSD; Post Traumatic Stress Disorder; Neuroplastogen

Outcome Measures

Primary Outcomes (3)

• Feasibility of one-day iTBS+DCS: Enrolment

  Enrollment rate: participants enrolled ÷ enrolment target by the end of 1.5 years will be ≥ 70% of the enrollment targe

  2 years

• Feasibility: Adherence

  Proportion of randomized participants receiving ≥80% of scheduled iTBS sessions, defined as ≥24 session

  2 years

• Feasibility: dropout rates

  Percentage of dropout rates attributable to the intervention will be ≤ 10%

  2 years

Other Outcomes (2)

• Treatment group differences in change from baseline to 3-weeks post-treatment on the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM 5 (CAPS-5) Total Severity Score

  3 weeks

• Treatment group differences in change from baseline to 6-weeks post-treatment on the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM 5 (CAPS-5) Total Severity Score

  6 weeks

Study Arms (2)

active aiTBS plus DCS

EXPERIMENTAL

Drug: D-Cycloserine (DCS); Device: Intermittent Theta Burst Stimulation (iTBS)

active aiTBS plus placebo DCS

PLACEBO COMPARATOR

Drug: Placebo; Device: Intermittent Theta Burst Stimulation (iTBS)

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.

active aiTBS plus DCS

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.

active aiTBS plus placebo DCS

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.

active aiTBS plus DCS; active aiTBS plus placebo DCS

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• are outpatients between the ages of 19-60;
• are voluntary and competent to consent;
• are first responders (active, on leave or retired);
• have DSM-5 diagnosis of PTSD with a CAPS for DSM-5 (CAPS-5) score ≥ 25;
• item Hamilton Depression Rating Scale score ≤ 23;
• have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
• if participating in psychotherapy, must have been in stable treatment for at least 1 month prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;
• able to adhere to the treatment schedule;
• Pass the TMS adult safety screening (TASS) questionnaire, and the MRI safety screening.

You may not qualify if:

• have a Severe Substance Use Disorder (except tobacco) within the last three (3) months;
• have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;
• have active suicidal intent;
• are pregnant;
• have a lifetime MINI diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;
• have a MINI diagnosis of OCD, or mood disorder that is assessed by a study investigator to be primary and causing greater impairment than PTSD;
• have a diagnosis of any personality disorder, assessed by a study investigator to be primary and causing greater impairment than MDD;
• have failed a course of ECT in the current episode or previous episode;
• have received rTMS for any previous indication;
• have any significant neurological disorder, history of seizure disorder (except those therapeutically induced by ECT), or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging;
• have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
• clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians (including but not limited to abnormal blood urea nitrogen (BUN), creatinine, estimated glomerular filtration rate (eGFR));
• currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy;
• currently take dicumarol, gingko biloba, isoniazid, ethionamide, fluphenazine, metrizamide, tramadol, warfarin due to potential interactions with D-Cycloserine;
• planned vaccination with Bacille Calmette-Guérin, cholera or typhoid or planned imaging procedure with an injectable die, within one week following the treatment days, due to potential interactions with DCS.

Sponsors & Collaborators

• Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA: lead

Study Sites (1)

Non-Invasive Neurostimulation Therapies Centre, University of British Columbia

Vancouver, British Columbia, V6T 2A1, Canada

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Fidel Vila-Rodriguez, M.D., PhD, FRCPC, DFAPA

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Ding, BSc

CONTACT

(604)-822-7308; ninet.lab@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, study doctors and raters obtaining outcome measures will be blind to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This trial is a two-parallel arm, randomized double-blind (patient, rater), placebo-controlled trial design.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)