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A Study on Functional Connectome and rTMS Intervention of Cognitive Flexibility Impairment in Patients With Major Depressive Disorder
Sponsor: Second Xiangya Hospital of Central South University
Summary
Persistent cognitive impairment in major depressive disorder (MDD) affects both treatment outcomes and psychosocial functioning, emphasizing the critical need for effective treatment. However, there is still a lack of effective treatment at present. Our previous studies found that the impairment in cognitive flexibility (CF) persisted even in remitted patients with MDD. This impairment was correlated with hypo-connectivity between the left inferior parietal lobule (IPL) and the right dorsal prefrontal cortex (dPFC). Based on these findings, we hypothesize that the hypo-connectivity between the left IPL and the right dPFC is the neural basis of CF impairment, and targeted interventions of this connection may alleviate CF impairment and thus improve treatment outcomes as well as psychosocial functioning of patients with MDD. The present study proposes to employ cognitive training for MDD patients with CF impairment. By comparing changes in CF and brain functional connectivity via task-based fMRI before and after the intervention, we aim to clarify the effect of cognitive training on cognitive performance, treatment outcomes and psychosocial functioning, and identify the critical role of the hypo-connectivity between the left IPL and the right dPFC underlying CF impairment. Furthermore, we will conduct a randomized controlled trial to investigate the effect of individualized dual-target repetitive transcranial magnetic stimulation (rTMS) on CF by targeting the hypo connectivity between the left IPL and the right dPFC. The results will further validate the critical role of this connection in modulating CF performance and provide a reliable intervention target for reducing CF impairment.
Official title: Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cognitive Flexibility and Brain Functional Connectivity in Patients With Major Depressive Disorder: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2025-09
Completion Date
2028-10
Last Updated
2025-09-08
Healthy Volunteers
Yes
Interventions
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
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.
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.
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.
Locations (1)
Xiangya Second Hospital of Central South University
Changsha, Hunan, China