Left vs. Right Non-Inferiority Trial
NCT04999553 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420
Last updated 2021-11-10
Summary
The aim of this study is to test the hypothesis that low-frequency rTMS (LFR) works as well as the established intermittent thetaburst rTMS (iTBS) treatment for treatment resistant depression (TRD).
Conditions
- Depression
- Major Depressive Disorder
- Major Depressive Episode
Interventions
- DEVICE
-
Repetitive Transcranial Magnetic Stimulation
rTMS will employ the MagPro X100/R30 stimulator equipped with the cool-B70 as we used a cool-B70 in our past non-inferiority trial. The dose will be a 120% rMT in accordance to our latest trial using iTBS. The target area to stimulate will be the right dorsolateral prefrontal cortex (DLPFC) for LFR and the left DLPFC for iTBS as established in prior clinical trials. The localization of both targets will follow the well-established procedures for either R-DLPFC or L-DLPFC using a heuristic method.
- DEVICE
-
Intermittent Theta Burst Stimulation (iTBS)
Intermittent Theta Burst Stimulation (iTBS)
- DEVICE
-
Low Frequency Right (LFR)
Low Frequency Right (LFR)
Sponsors & Collaborators
-
Centre for Addiction and Mental Health
collaborator OTHER -
University of British Columbia
lead OTHER
Principal Investigators
-
Fidel Vila-Rodriguez, MD, PhD · University of British Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-08
- Primary Completion
- 2026-02-01
- Completion
- 2026-02-01
Countries
- Canada
Study Locations
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