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

Major Depressive Disorder Major Depressive Episode

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

Inclusion Criteria7

are outpatients;
are voluntary and competent to consent to treatment;
are ≥ 18 years;
have a score ≥ 26 on the IDS-30-SR;
have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
able to adhere to the treatment schedule;
pass the TMS adult safety screening (TASS) questionnaire

Exclusion Criteria10

have active suicidal intent;
are pregnant;
have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months;
have a concomitant major unstable medical illness;
have any significant form of dementia or any history of epilepsy;
have any intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;
If they are taking psychotropic medication, be on a stable dose for 4 weeks before starting treatment, and no initiation of new regular psychotropic medication;
have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

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.