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RECRUITING
NCT06986460
PHASE3

Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression

Sponsor: Tyler Kaster

View on ClinicalTrials.gov

Summary

The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC. This work will develop the evidence supporting the use of LFR rTMS for individuals with treatment-resistant BD-DE who currently have limited treatment options to alleviate their suffering. Participants will come for 30 days of LFR, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-05-27

Completion Date

2030-05

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DEVICE

MagPro X100/R30 stimulator, Cool-B70 coil

1Hz rTMS delivered to the right DLPFC

Locations (2)

University Health Network Toronto Western Hospital

Toronto, Ontario, Canada

Centre For Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada