Structural Mechanisms of Dual-Target tDCS in Stroke Hemiparetic Hand

NCT07605039 | Not Yet Recruiting

• 1 other identifier: MQ2025041
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Broetz Hand Function Score

  Baseline (T0), post-intervention (T1, after 4 weeks), 6-month follow-up (T2)

Study Arms (2)

Active Dual M1 tDCS

EXPERIMENTAL

Device: tDCS

Sham Dual M1 tDCS

SHAM COMPARATOR

Device: Sham tDCS

Interventions

tDCS DEVICE

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.

Active Dual M1 tDCS

Sham tDCS DEVICE

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.

Sham Dual M1 tDCS

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with stroke according to the "Diagnostic Criteria for Major Cerebrovascular Diseases in China, 2019", confirmed by cranial CT or MRI.
• First-ever unilateral subcortical stroke (involving the corona radiata, basal ganglia, thalamus, internal capsule, etc.).
• Age 30-75 years.
• Right-handed prior to stroke onset.
• Stroke onset ≥ 2 weeks.
• Hemiplegic hand function at Brunnstrom Stage I-III.
• Written informed consent provided by the patient or legally authorized representative.

You may not qualify if:

• Any contraindications to MRI.
• History of other neurological disorders or substance abuse.
• Unstable conditions or rapidly progressive/malignant diseases, e.g., severe atrial fibrillation.
• Severe skin allergies.
• Inability to cooperate with basic communication or assessments, such as severe aphasia.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-01