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RECRUITING
NCT06112652
NA

Neuromodulation of Different Doses to Treat TRD Guided by pBFS Technique

Sponsor: Changping Laboratory

View on ClinicalTrials.gov

Summary

The aim of this study is to explore the effectiveness and safety of different doses of neural regulation under the guidance of pBFS technology in improving symptoms in patients with moderate to severe depressive disorders.

Official title: The Dosage Effect of Personalized Brain Functional Sectors(pBFS) Guided rTMS Treatment for Treatment-resistance Depression: a Randomized, Double-Blind, Sham-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-12-04

Completion Date

2025-12-30

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DEVICE

4 session rTMS

Participants will receive 4 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

DEVICE

6 session rTMS

Participants will receive 6 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

DEVICE

8 session rTMS

Participants will receive 8 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

DEVICE

10 session rTMS

Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

DEVICE

sham rTMS

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.

Locations (2)

Lei He

Zhumadian, Henan, China

Wuhan Mental Health Center

Wuhan, China