NCT05976009

pBFS-Guided rTMS Therapy Over Different Targets for Treatment-Resistant Depression

Personalized Brain Functional Sector-guided rTMS Therapy Over Different Targets for Treatment-resistant Depression

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.

Detailed description

Stimulation of the dorsolateral prefrontal cortex(DLPFC) and ventromedial prefrontal cortex (DMPFC) as target sites for rTMS intervention in depressive disorders has shown some therapeutic efficacy. However, overall patient response rates remain suboptimal, partly because the prefrontal cortex is a large region encompassing multiple functional networks. Analyses suggest that targeting different targets within the dorsolateral and ventromedial prefrontal cortex for intervention in depressive disorder patients may activate distinct functional networks. Therefore, selecting appropriate targets within the prefrontal cortex that accurately modulate the functional networks involved in depressive disorder patients is crucial for achieving effective clinical outcomes. Fox et al. have demonstrated that clinical response and individualized target sites in the dorsolateral prefrontal cortex are associated with functional connectivity to the subgenual cingulate cortex (sgACC). However, some analyses have indicated that rTMS target sites based solely on minimal sgACC connectivity may not be optimal for all depressive symptoms. Therefore, identifying individualized stimulation targets that improve core symptoms in depressed patients is important for achieving more effective personalized treatment of depressive disorders. This study aims to explore the efficacy and safety of rTMS interventions targeting 40 prefrontal cortex sites in depressive disorder patients and functional imaging-based mechanisms for optimal stimulation targets. 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 assigned a random intervention target from 40 prefrontal cortex sites. Then all participants will undergo a 14-day rTMS modulation and a week follow-up visit. Participants will keep a stable treatment regime during treatment and follow-up.

Conditions

• Major Depressive Disorder
• Treatment Resistant Depression
• MDD

Interventions

Type	Name	Description
DEVICE	active rTMS stimulating	Two sessions of active rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.

Timeline

• Start date: 2023-08-29
• Primary completion: 2024-08-15
• Completion: 2024-09-20
• First posted: 2023-08-04
• Last updated: 2024-02-07

Locations

1 site across 1 country: China