pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Depression

Status Recruiting

Clinical Trial Summary

We aim to evaluate the safety and efficacy of pBFS-guided high-dose rTMS therapy with short inter-session interval for patients with treatment-resistant depression

Clinical Trial Description

Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. Currently, the FDA cleared the SAINT Neuromodulation System for the treatment of Treatment-Resistant Depression(TRD) over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been effective in a short period of time for treatment-resistant depression. The limitation of this approach includes the long inter-session interval (~50min) of the treatment, patients need to wait about 8 hours for 10 session's intervention per day. Therefore, it is urgent to explore the efficacy and safety of rTMS with a short inter-session interval (e.g. 20 min) that is more acceptable for TRD patients. After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1:1 ratio to the active short-interval rTMS group, active short-interval rTMS group, and active long-interval rTMS group. Then all participants will undergo a 5 day rTMS modulation followed by a four-week follow-up visit. ;

Study Design

Related Conditions & MeSH terms

Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Treatment-Resistant Depression

Clinical Trial Details

NCT number	NCT05842291
Study type	Interventional
Source	Changping Laboratory
Contact	Meiling Li, Ph.D.
Phone	010-80726688
Email	meilingli@cpl.ac.cn
Status	Recruiting
Phase	N/A
Start date	June 19, 2023
Completion date	November 1, 2024

View Details

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