NCT05577481

Neuronavigation Guided iTBS With Personalized Target for Depression

Research on the Efficacy and Brain Network Mechanism of Personalized Targeting Intermittent Theta Burst Stimulation (iTBS) Based on Functional Magnetic Resonance Imaging for the Treatment of Major Depressive Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.

Conditions

• Depression

Interventions

Type	Name	Description
COMBINATION_PRODUCT	sham iTBS combined with antidepressants	Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
COMBINATION_PRODUCT	iTBS combined with antidepressants	Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.

Timeline

• Start date: 2023-07-10
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2022-10-13
• Last updated: 2024-05-23

Locations

1 site across 1 country: China