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

Sponsor
Second Xiangya Hospital of Central South University
Study ID
NCT07161492
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Repetitive Transcranial Magnetic Stimulation — DEVICE
    Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that uses magnetic pulses to modulate neuronal activity in targeted cortical regions. In this study, rTMS is delivered using a commercially available magnetic stimulator with a figure-of-eight coil. Stimulation targets - the left inferior parietal lobule (IPL) and the right dorsolateral prefrontal cortex (DLPFC) - are individually localized using MRI-guided neuronavigation based on each participant's structural magnetic resonance imaging. Each stimulation session consists of paired target stimulation (IPL and DLPFC) with a 50-minute inter-session interval. Treatment is administered as 5 paired sessions per day for 10 consecutive days. Sham stimulation uses the same device and coil placement but delivers no active magnetic stimulation, mimicking the sensory experience of active r

Study Details

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.

Key Dates

First listed
Sep 8, 2025
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Dual-Target rTMS Group
    Participants receive active repetitive transcranial magnetic stimulation (rTMS) over both the left inferior parietal lobule (IPL) and the right dorsolateral prefrontal cortex (DLPFC) using MRI-guided neuronavigation. Stimulation is delivered in 5 paired sessions per day (with a 50-minute inter-session interval) for 10 consecutive days. All participants continue stable SSRI or SNRI antidepressant treatment as usual (TAU).
  • Active Comparator: Active Single-Target rTMS Group
    Participants receive active rTMS over the left inferior parietal lobule (IPL) and sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) using MRI-guided neuronavigation. Stimulation is delivered in 5 paired sessions per day (with a 50-minute inter-session interval) for 10 consecutive days. All participants continue stable SSRI or SNRI antidepressant treatment as usual (TAU).
  • Sham Comparator: Sham rTMS Control Group
    Participants receive sham rTMS over both the left inferior parietal lobule (IPL) and the right dorsolateral prefrontal cortex (DLPFC) using MRI-guided neuronavigation. Sham stimulation mimics the sensation of active rTMS without delivering magnetic stimulation. Stimulation is delivered in 5 paired sessions per day (with a 50-minute inter-session interval) for 10 consecutive days. All participants continue stable SSRI or SNRI antidepressant treatment as usual (TAU).

Primary Outcome Measure

Change in Cognitive Flexibility [ Time Frame: Baseline, immediately post-treatment (Day 10), and at 2-week and 4-week follow-ups ]

Central Contacts

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