RecruitingNot ApplicableNCT05028738

Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety


Sponsor

University of British Columbia

Enrollment

100 participants

Start Date

Oct 11, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This trial compares intermittent theta-burst stimulation (iTBS) to low frequency repetitive transcranial magnetic stimulation (LFR) in regards to depression and anxiety outcomes in 100 patients with treatment resistant depression (TRD).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests transcranial magnetic stimulation (TMS) — a non-invasive brain stimulation technique — for treating depression and anxiety in outpatients. TMS uses magnetic pulses to stimulate specific areas of the brain. This study is designed as a pragmatic trial, meaning it reflects real-world treatment conditions. **You may be eligible if...** - You are 18 or older - You are an outpatient seeking treatment for depression or anxiety - You score 26 or higher on the IDS-30-SR depression scale - You have not changed or started any psychiatric medications in the past 4 weeks - You pass the TMS safety screening **You may NOT be eligible if...** - You have active thoughts of suicide - You are pregnant - You have schizophrenia, bipolar type I, or active psychotic symptoms - You have dementia, epilepsy, or brain implants (clips, stimulators, cochlear implants) - You have a serious unstable medical illness - You have metal objects in or near your head Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERepetitive Transcranial Magnetic Stimulation

rTMS will employ the MagPro X100 stimulator equipped with the cool-B70 coil (MagVenture, Farum, Denmark). The dose will be a 120% resting motor threshold (rMT) in accordance to our latest trial using iTBS. Localization of the right and left DLPFC will follow the well-established Beam F3 procedure. Subjects will then undergo 30 sessions of rTMS, once daily on weekdays for 6 weeks. FDA-approved iTBS protocol will consist of bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz for 600 pulses total, 2 s on, 8 s off, for 3 min 9 sec, at 120% rMT. LFR will consist of 1 Hz stimulation consisting of a single train of 10min duration for 600 pulses total at 120% rMT.


Locations(1)

Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry

Vancouver, British Columbia, Canada

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NCT05028738


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