A Study on Functional Connectome and rTMS Intervention of Cognitive Flexibility Impairment in Patients With Major Depressive Disorder

NANot yet recruitingINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

October 31, 2028

Conditions
Depressive Disorder, MajorCognitive Impairment
Interventions
DEVICE

Repetitive Transcranial Magnetic Stimulation

"Individualized dual-target rTMS delivered using MRI-guided neuronavigation (Dolphin Robotics). Stimulation parameters:~* Targets: Left IPL and right dPFC connectivity hotspots~* Protocol: 100 pulse-pairs/session at 0.2Hz~* Intensities: Conditioning stimulus 90% RMT, test stimulus 120% RMT~* Duration: 8.3 min/session, 5 sessions/week × 4 weeks"

BEHAVIORAL

Computerized Cognitive Remediation Therapy

Structured computer-based training targeting cognitive flexibility, consisting of 4-6 exercises per session. Each exercise includes 8-24 progressively challenging tasks. Administered for 45-60 minutes per session, 5 sessions/week over 4 weeks. Delivered via specialized software on desktop computers.

DEVICE

Sham Repetitive Transcranial Magnetic Stimulation

"Inactive stimulation using identical equipment with:~* Coil tilted at 90° to scalp~* Magnetic shielding insert~* Matched acoustic artifact All other parameters identical to active rTMS arm."

DRUG

Selective Serotonin Reuptake Inhibitors or Serotonin-Norepinephrine Reuptake Inhibitors

"Background antidepressant therapy maintained at stable doses throughout the study. Minimum dose requirements:~* SSRIs: Paroxetine ≥20mg/day, Sertraline ≥50mg/day~* SNRIs: Venlafaxine ≥75mg/day, Duloxetine ≥60mg/day Dosage adjustments prohibited during trial participation."

Trial Locations (1)

410011

Xiangya Second Hospital of Central South University, Changsha

All Listed Sponsors
lead

Second Xiangya Hospital of Central South University

OTHER

NCT07161492 - A Study on Functional Connectome and rTMS Intervention of Cognitive Flexibility Impairment in Patients With Major Depressive Disorder | Biotech Hunter | Biotech Hunter