NCT06986460

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tyler Kaster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Depression Depressed Phase

Interventions

Type	Name	Description
DEVICE	MagPro X100/R30 stimulator, Cool-B70 coil	1Hz rTMS delivered to the right DLPFC

Timeline

• Start date: 2025-05-27
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2025-05-23
• Last updated: 2026-03-18

Locations

2 sites across 1 country: Canada