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NOT YET RECRUITING
NCT07605039
NA

Structural Mechanisms of Dual-Target tDCS in Stroke Hemiparetic Hand

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

This is a single-center, randomized, single-blind study investigating the effects of dual-target transcranial direct current stimulation (tDCS) combined with task-oriented functional electrical stimulation on upper limb recovery in patients with non-acute post-stroke hemiplegia. A total of 56 participants will be recruited and randomly assigned (1:1) to the dual M1 tDCS group or sham stimulation group. The intervention is delivered five times per week for four weeks, with 20 sessions in total. Multimodal MRI (T1W, T2W, and DTI) will be used to assess structural and network-level reorganization of sensorimotor pathways, including the corticospinal tract, in response to tDCS. The primary outcome is the Broetz hand function score, evaluated at baseline, post-intervention, and six-month follow-up. Secondary outcomes include Fugl-Meyer Assessment of the upper extremity (FMA-UE) and multimodal MRI-derived measures of white matter integrity. This study aims to elucidate the structural constraints underlying sensorimotor network lateralization and to identify responder and non-responder profiles based on corticospinal tract damage, providing mechanistic insight into individualized tDCS-based neurorehabilitation after stroke.

Official title: Multimodal MRI-Based Study of the Structural Mechanisms Underlying Interhemispheric Network Reorganization Induced by Dual-Target tDCS in Stroke Hemiparetic Hand

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-05-06

Completion Date

2028-12-31

Last Updated

2026-05-22

Healthy Volunteers

No

Conditions

Interventions

DEVICE

tDCS

Bilateral M1 high-definition transcranial direct current stimulation (HD-tDCS) at 2 mA for 20 minutes per session, delivered five times per week for 4 weeks (total 20 sessions). Electrodes are placed over the left and right primary motor cortices. Each session is combined with task-oriented hand rehabilitation exercises targeting the affected upper limb. This intervention is designed to modulate interhemispheric sensorimotor network reorganization and promote hand function recovery after stroke.

DEVICE

Sham tDCS

Bilateral M1 sham HD-tDCS: electrodes placed identically to the active group, with current ramped up and down for 10 seconds at the start and end of each 20-minute session, without sustained stimulation. Sessions are also combined with task-oriented hand rehabilitation exercises. This sham intervention serves as a control to evaluate the efficacy of active tDCS on interhemispheric network reorganization and hand function recovery.