Actively Recruiting
Patient-oriented Randomized Pragmatic Trial Comparing Two Types of Repetitive Transcranial Magnetic Stimulation in Treatment Resistant Depression and Anxiety
Led by University of British Columbia · Updated on 2024-12-20
100
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of repetitive transcranial magnetic stimulation (rTMS) treatments—intermittent theta-burst stimulation (iTBS) and low frequency repetitive stimulation (LFR)—in 100 patients with treatment-resistant depression (TRD). This pragmatic trial aims to test the feasibility of recruiting patients with fewer restrictions, compare different depression and anxiety rating scales, gather patient preferences on treatment options and digital biomarker use, and develop a statistical model to personalize treatment choices during the trial. Participants will receive rTMS using the MagPro X100 device with the cool-B70 coil, applying a dose at 120% resting motor threshold. Treatments target the left or right dorsolateral prefrontal cortex (DLPFC) using the Beam F3 localization method. Patients will complete 30 daily sessions on weekdays over six weeks. The iTBS protocol delivers bursts of 3 pulses at 50 Hz repeated at 5 Hz for 600 pulses total in about 3 minutes. The LFR protocol provides a continuous 1 Hz stimulation with 600 pulses over 10 minutes. During the study, patients will be assessed using depression and anxiety scales, and their input about treatment choices and digital phenotyping will be collected. Researchers will monitor recruitment and retention rates as well as the acceptance of digital phenotyping surveys. The primary outcome is depression severity measured one week after treatment. Safety and adherence to the treatment schedule will be closely tracked throughout the study period.
CONDITIONS
Official Title
Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be an outpatient
- Be at least 18 years old
- Have a score of 26 or higher on the IDS-30-SR depression scale
- Have had no increase or start of any psychotropic medication in the 4 weeks before screening
- Be able to follow the treatment schedule
- Pass the TMS adult safety screening (TASS) questionnaire
- Be voluntary and competent to consent to treatment
You will not qualify if you...
- Have active suicidal intent
- Be pregnant
- Have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder, or recent psychotic symptoms within the last 3 months
- Have a major unstable medical illness
- Have significant dementia or a history of epilepsy
- Have intracranial implants or metal objects near the head that cannot be safely removed
- Be in psychotherapy without stable treatment for at least 3 months before the study or expect therapy changes during the study
- Have started or changed psychotropic medication doses within 4 weeks before treatment
- Have clinically significant lab abnormalities as judged by investigators
- Have a sensory impairment that prevents cooperation with interviews
AI-Screening
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Trial Site Locations
Total: 1 location
1
Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry
Vancouver, British Columbia, Canada, V6T 2A1
Actively Recruiting
Research Team
J
Jessica Layton
M
Michelle Avina, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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