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Behavioural Intervention
E-field Guided iTBS for Depression
N/A
Recruiting
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from pre- and post-intervention (average of 6 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if personalizing rTMS helps improve treatment response in people with mental health issues.
Who is the study for?
This trial is for adults aged 18-65 with major depressive disorder who haven't responded to certain antidepressants. They must score ≥18 on the HRSD-17, be outpatients, consent to treatment, and keep their current medication stable. Exclusions include unstable medical conditions, pregnancy, metal implants affecting MRI or TMS safety, inadequate English fluency, recent psychotherapy changes, certain psychiatric diagnoses or substance use disorders.
What is being tested?
The study tests personalized repetitive transcranial magnetic stimulation (rTMS) using intermittent theta burst stimulation (iTBS). Participants will receive iTBS either with standard targeting/intensity or tailored to individual brain activity markers via MRI and E-field modeling measures.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of rTMS can include headaches, scalp discomfort at the site of stimulation, lightheadedness and rare risk of seizure. Personal experiences may vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from pre- and post-intervention (average of 6 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre- and post-intervention (average of 6 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mental Depression
Markers of cortical excitation
Secondary study objectives
Tumor Markers
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Course A: E-field ModelingExperimental Treatment1 Intervention
Your Magnetic Resonance Image (MRI) results and rTMS calibration information (motor threshold) will be used to create a brain model and identify the targeted location, iTBS coil position and intensity for your iTBS rTMS treatment. You will undergo iTBS rTMS treatment in this study for 6 weeks. There will be 5 iTBS treatment sessions per week, lasting approximately 3 minutes each, once daily for 5 days in a row (always Monday to Friday). Each day after treatment, you will also complete a brief set of questionnaires to track your symptoms, which will take 15 minutes. After every 5 treatments, you will complete an extra interview that will take an additional 30 minutes. There will also be two follow-up visits at 1 and 4 weeks after the end of treatment, each lasting approximately 1 hour. During these follow-up visits, you will be asked to complete a brief set of questionnaires and interviews to monitor your symptoms.
Group II: Treatment Course B: Beam F3Active Control1 Intervention
The targeted iTBS rTMS treatment location and intensity will be determined via standard parameters, specifically anatomical landmarks and your rTMS calibration information (motor threshold). You will undergo iTBS rTMS treatment in this study for 6 weeks. There will be 5 iTBS treatment sessions per week, lasting approximately 3 minutes each, once daily for 5 days in a row (always Monday to Friday). Each day after treatment, you will also complete a brief set of questionnaires to track your symptoms, which will take 15 minutes. After every 5 treatments, you will complete an extra interview that will take an additional 30 minutes. There will also be two follow-up visits at 1 and 4 weeks after the end of treatment, each lasting approximately 1 hour. During these follow-up visits, you will be asked to complete a brief set of questionnaires and interviews to monitor your symptoms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iTBS
2019
Completed Phase 3
~640
Find a Location
Who is running the clinical trial?
University Health Network, TorontoOTHER
1,531 Previous Clinical Trials
504,212 Total Patients Enrolled
56 Trials studying Depression
11,347 Patients Enrolled for Depression
Centre for Addiction and Mental HealthLead Sponsor
375 Previous Clinical Trials
82,777 Total Patients Enrolled
93 Trials studying Depression
17,671 Patients Enrolled for Depression