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

ConditionsDepressive Disorder, Major Cognitive Impairment

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

SponsorSecond Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

105 Participants

are divided into 3 treatment groups

Group A: Active Dual-Target rTMS GroupExperimental treatment 1 intervention

Group B: Active Single-Target rTMS GroupActive comparator 1 intervention

Group C: Sham rTMS Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Cognitive Flexibility

Time frame

Baseline, immediately post-treatment (Day 10), and at 2-week and 4-week follow-ups

Secondary outcomes

Change in Depressive Symptom Severity

Time frame

Baseline, immediately post-treatment (Day 10), and at 2-week and 4-week follow-ups

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Xiangya Hospital of Central South University

Lead sponsor

Fujian Mental Health Center

Collaborator

Xianyue Hospital, Xiamen