NCT06350396

pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression

rTMS Intervention for DMPFC Treatment of Treatment-Resistant Depression Under the Guidance of Personalized Brain Functional Area Dissection (pBFS) Technology

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression.

Detailed description

Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The dorsomedial prefrontal cortex (DMPFC), which serves as a connection intermediary of the aberrant functional network in cognitive control and rumination in depression, is highly correlated with disease manifestations and post-treatment improvements through several studies involving neuroimaging and brain injury. Research has shown that the response of DMPFC to rTMS is more subject to improving the dimensions of anxiety and insomnia in depression. Therefore, exploring the novel target DMPFC is also beneficial for distinguishing disease dimensions in the future, thereby enabling personalized treatment and improving clinical treatment efficacy. 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 double-blind in a 1:1 ratio to the active rTMS group, or sham-control group. Then all participants will undergo a 21-day rTMS modulation and a 3-week, 9-week, and 6-month post-treatment follow-up visit.

Conditions

• Treatment Resistant Depression
• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	active rTMS treatment	Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.
DEVICE	sham rTMS treatment	The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.

Timeline

• Start date: 2024-04-17
• Primary completion: 2024-12-30
• Completion: 2025-06-30
• First posted: 2024-04-05
• Last updated: 2024-05-07

Locations

5 sites across 1 country: China