NCT04497350

Transcranial Magnetic Stimulation vs Theta Burst Stimulation in Major Depressive Disorder

A Blinded, Randomized Trial Comparing the Effects of Transcranial Magnetic Stimulation and Theta Burst Stimulation in Patients With Major Depressive Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the differences in efficacy between transcranial magnetic stimulation (TMS) and intermittent theta burst stimulation (iTBS) treatment in subjects suffering from major depressive disorder.

Detailed description

Up to 30 patients of any gender aged from 18 to 70 years old will be recruited for inclusion once candidacy has been established by screening criteria. Once recruited, patients will be randomly assigned to the TMS treatment group or the iTBS treatment group. Patients will be blinded to their group assignment, but will be informed of their assignment upon the final outcome measure collection timepoint (e.g., 1 month post-treatment). Patients who failed to respond by 1-month post iTBS or TMS treatment will be allowed to cross-over into the other treatment group and will be re-enrolled into the study. For patients assigned to the TMS treatment group, the treatment protocol will consist of 20 sessions of TMS treatment. Each TMS session will deliver 5,000 pulses (120-140% MT, continuous temperature of 24C) over an 61 minute, 51 second time period. Patients will have one TMS session per day, five days a week, until their treatment is completed (approximately four weeks). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline. For patients assigned to the iTBS treatment group, the treatment protocol will consist of 20 sessions of iTBS treatment. Each iTBS session will deliver 1,800 pulses (120-140% MT, continuous temperature of 24C) over an 9-minute-40-second period. Patients will have up to four iTBS sessions per day, five days a week, until their treatment is completed (approximately 1 week). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation	5,000 pulses (120-140% MT, continuous temperature of 24C) will be delivered per session (see Appendix A for timing parameters). Patients will have one TMS session per day, five days a week, until their treatment is completed (approximately four weeks).
DEVICE	Theta Burst Stimulation	One session of iTBS will deliver 1,800 pulses (120-140% MT, continuous temperature of 22ºC) over an 9-minute-40-second period. The minimum break period between iTBS sessions is 25 minutes.

Timeline

• Start date: 2020-01-06
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2020-08-04
• Last updated: 2022-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study