An interventional study of Accelerated intermittent theta burst stimulation in Post Traumatic Stress Disorder PTSD and Major Depressive Disorder (MDD), sponsored by Lawson Research Institute of St. Joseph's. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment
The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).
The main questions this study aims to answer are:
Participants will:
This is a single-arm, open-label pilot feasibility study of accelerated intermittent theta burst stimulation, also called accelerated iTBS, in adults with both post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). The study is designed to assess whether an accelerated iTBS schedule can be delivered safely, tolerably, and feasibly in a clinical setting. The main focus is feasibility, including recruitment, treatment adherence, participant retention, safety, tolerability, and participant acceptability. About 12 to 16 participants will receive active accelerated iTBS. Treatment will include six short stimulation sessions per day over five consecutive days, for a total of 30 sessions. The study will also collect exploratory information over time on depression symptoms, PTSD symptoms, anxiety, daily functioning, quality of life, and brain activity measured by EEG. Because this is a small pilot study, the analysis will be mainly descriptive. The results will help refine study procedures and guide the design of a larger future clinical trial.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 16 is below the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Lawson Research Institute of St. Joseph's is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive active accelerated intermittent theta burst stimulation (iTBS). Treatment will consist of six short stimulation sessions per day delivered over five consecutive days, for a total of 30 sessions.
Device: Accelerated intermittent theta burst stimulation
Accelerated intermittent theta burst stimulation, also called accelerated iTBS, is a non-invasive magnetic brain stimulation intervention. Stimulation is delivered to the left dorsolateral prefrontal cortex using a transcranial magnetic stimulation system. Participants receive six short sessions per day over five consecutive days.
Recruitment rate
Recruitment rate will be assessed as the number of participants enrolled per month during the active recruitment period.
Time frame: Study recruitment period, up to 12 months
Consent rate
Consent rate will be assessed as the proportion of eligible individuals approached who provide informed consent.
Time frame: Study recruitment period, up to 12 months
Treatment adherence
Treatment adherence will be assessed as the percentage of scheduled accelerated iTBS sessions completed during the 5-day treatment course.
Time frame: Treatment Days 1 through 5
Retention through Week 12 follow-up
Retention will be assessed as the proportion of enrolled participants who complete the Week 12 follow-up visit.
Time frame: Baseline through Week 12
Adverse events
Adverse events will be assessed as the proportion of participants who experience one or more adverse events during treatment and follow-up.
Time frame: Treatment Days 1 through Week 12
Serious adverse events
Serious adverse events will be assessed as the proportion of participants who experience one or more serious adverse events during treatment and follow-up.
Time frame: Treatment Days 1 through Week 12
Discontinuations due to adverse events
Tolerability will be assessed as the proportion of participants who discontinue accelerated iTBS because of adverse events.
Time frame: Treatment Days 1 through Week 12
Participant satisfaction with accelerated iTBS
Participant satisfaction will be assessed using a 5-point Likert satisfaction rating scale. Scores range from 1 to 5, with higher scores indicating greater satisfaction.
Time frame: Week 2, Week 5, and Week 12
Participant feedback on accelerated iTBS
Participant feedback will be assessed using brief feedback questions about the accelerated iTBS treatment schedule and overall study experience. Responses will be summarized descriptively.
Time frame: Week 2, Week 5, and Week 12
Exploratory change in clinician-rated depression symptom severity measured by HAMD-17
Clinician-rated depression symptom severity will be assessed using the Hamilton Depression Rating Scale-17. Total scores range from 0 to 52, with higher scores indicating greater depression symptom severity.
Time frame: Baseline, Week 2, Week 5, and Week 12
Exploratory change in self-reported depression symptom severity measured by PHQ-9
Self-reported depression symptom severity will be assessed using the Patient Health Questionnaire-9. Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.
Time frame: Baseline, Week 2, Week 5, and Week 12
Exploratory change in self-reported PTSD symptom severity measured by PCL-5
Self-reported PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Time frame: Baseline, Week 2, Week 5, and Week 12
Exploratory change in clinician-rated PTSD symptom severity measured by CAPS-5
Clinician-rated PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5. Total symptom severity scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Time frame: Baseline, Week 2, and Week 12
Exploratory change in anxiety symptom severity measured by GAD-7
Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 item Scale. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Time frame: Baseline, Week 2, Week 5, and Week 12
Exploratory change in cognitive function measured by MoCA
Cognitive function will be assessed using the Montreal Cognitive Assessment. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame: Baseline, Week 2, Week 5, and Week 12
Exploratory change in functioning and disability measured by WHODAS 2.0
Functioning and disability will be assessed using the WHO Disability Assessment Schedule 2.0
Time frame: Baseline, Week 2, Week 5, and Week 12
Exploratory change in quality of life measured by Q-LES-Q-SF
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form.
Time frame: Baseline, Week 2, Week 5, and Week 12
Baseline clinical global severity measured by CGI-S
Clinical global severity will be assessed using the Clinical Global Impression-Severity scale. Scores range from 1 to 7, with higher scores indicating greater illness severity.
Time frame: Baseline
Exploratory change in clinical global improvement measured by CGI-I
Clinical global improvement will be assessed using the Clinical Global Impression-Improvement scale. Scores range from 1 to 7, with lower scores indicating greater clinical improvement.
Time frame: Week 2, Week 5, and Week 12
Exploratory change in resting-state EEG alpha power
Resting-state EEG alpha power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
Time frame: Baseline, Treatment Day 1, and Treatment Day 5
Exploratory change in resting-state EEG gamma power
Resting-state EEG gamma power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
Time frame: Baseline, Treatment Day 1, and Treatment Day 5
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
Of 73 non-industry interventional studies with no phase under Combat Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 9 months is below that.
Counting every sponsor, half of 79 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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Lawson Research Institute of St. Joseph's