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Brain Functional Connectivity Mechanism of Cognitive Flexibility Impairment and rTMS Intervention in Major Depressive Disorder

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 182 to 105 Start date: Sep 2025 to Jul 2026 · Primary endpoint revised · Interventions: Computerized Cognitive Remediation Therapy (Behavioral), Repetitive Transcranial Magnetic Stimulation (Device), Selective Serotonin… to Repetitive Transcranial Magnetic Stimulation (Device) · 7 morev2 Show 10 more changesShow less
    • Start date: Sep 2025 to Jul 2026
    • Primary endpoint revised
    • Interventions: Computerized Cognitive Remediation Therapy (Behavioral), Repetitive Transcranial Magnetic Stimulation (Device), Selective Serotonin… to Repetitive Transcranial Magnetic Stimulation (Device)
    • Eligibility criteria expanded, about 120 words
    • Study description expanded, about 144 words
    • Collaborators expanded, about 7 words
    • Publications: details revised at 11 of 11 entries
    • Study arms: 4 to 3
    • Secondary endpoints expanded, about 5 words
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Major depressive disorder (MDD) often involves cognitive deficits, particularly in cognitive flexibility, which is inadequately addressed by standard antidepressants. This study tests an innovative brain stimulation regimen: individualized dual-target repetitive transcranial magnetic stimulation (rTMS) to improve cognitive flexibility in MDD patients. This is a randomized, double-blind, sham-controlled trial that plans to enroll 105 MDD patients with cognitive flexibility impairment. Participants will be randomly assigned to one of three groups: (1) Active dual-target group - receiving active rTMS over both the left inferior parietal lobule (IPL) and the right dorsolateral prefrontal cortex (DLPFC); (2) Active single-target group - receiving active rTMS over the left IPL and sham stimulation over the right DLPFC; (3) Sham control group - receiving sham stimulation over both targets. All participants will continue their stable antidepressant medication (SSRI or SNRI). The rTMS intervention lasts 10 days, with 5 stimulation sessions per day. Cognitive flexibility, depressive symptoms, and brain functional connectivity will be assessed at baseline, immediately after the 10-day treatment, and at 2-week and 4-week follow-ups using neurocognitive tests, clinical rating scales (e.g., HAMD), and functional MRI. The results will help confirm the role of the IPL-DLPFC connectivity in cognitive flexibility and may establish a new treatment target for cognitive dysfunction in MDD.
Trial Details
NCT Number NCT07161492
Lead Sponsor Second Xiangya Hospital of Central South University
Collaborators: Fujian Mental Health Center, Xianyue Hospital, Xiamen
Conditions Depressive Disorder, Major, Cognitive Impairment
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov