Health TrialsbyHealthPanel

ONE-P TMS First Responders

ConditionPTSD - Post Traumatic Stress Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-60
SponsorFidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: active aiTBS plus DCSExperimental treatment 2 interventions
Group B: active aiTBS plus placebo DCSPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
2 years
2

Feasibility: Adherence

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

Time frame
2 years
3

Feasibility: dropout rates

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

Time frame
2 years

Secondary outcomes

Other outcomes

1

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

Exploratory efficacy outcome: change in Clinician-Administered PTSD Scale for DSM 5 (CAPS-5). Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 3-weeks after the intervention

Time frame
3 weeks
2

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

Exploratory efficacy outcome: change in Clinician-Administered PTSD Scale for DSM 5 (CAPS-5). Total Severity Score (20-item sum, range 0-80, higher score=greater severity) in change from baseline to 6-weeks after the intervention. Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, \& Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013

Time frame
6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA

Lead sponsor

University of British Columbia

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: