Accelerated iTBS for PTSD and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLawson Research Institute of St. Joseph's
About this trial
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:
1. Can participants complete six short brain stimulation sessions per day for five days? 2. Is this treatment schedule safe and tolerable for participants? 3. What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?
Participants will:
1. Complete health screening and baseline assessments. 2. Receive six short sessions of magnetic brain stimulation per day for five days. 3. Have their brain activity measured using an EEG recording. 4. Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Current post-traumatic stress disorder (PTSD) and current major depressive disorder (MDD), confirmed by a structured diagnostic interview (e.g., MINI 6.0 using the PTSD and MDD modules).
Minimum symptom severity at baseline: HAMD-17 score ≥14 (moderate depression) and/or PCL-5 score ≥33 (probable PTSD).
On a stable pharmacologic and/or psychotherapeutic regimen for at least 4 weeks prior to baseline, and willing to maintain stability during the treatment phase, unless medically necessary.
Disqualifiers
Neurologic or device-related risks, including seizure history, traumatic brain injury with loss of consciousness greater than 5 minutes, major neurologic illness, or metal/electronic implants contraindicated for transcranial magnetic stimulation.
Psychiatric or substance-related risks, including current psychotic disorder, acute mania, diagnosis of Bipolar I or Bipolar II disorder, recent substance use disorder, or imminent suicide risk.
Medical or medication-related risks, including unstable severe illness, high-risk medications, hearing impairment, unwillingness to use ear protection, or prior non-response to an adequate course of theta burst stimulation for the current depression/PTSD episode.
Enrollment in another interventional trial.
Trial design
Design model
Single group
Treatments tested in this trial
Accelerated intermittent theta burst stimulation
DeviceAccelerated 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.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Accelerated iTBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 54
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 12Secondary outcomes
1
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 122
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 123
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 124
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 12Sponsors and contacts
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Source ClinicalTrials.gov