Left vs. Right Non-Inferiority Trial

NCT04999553 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2021-11-10

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04999553 on ClinicalTrials.gov