Structural Mechanisms of Dual-Target tDCS in Stroke Hemiparetic Hand

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.

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Key information

Conditions

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

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

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.

Primary outcomes

Broetz Hand Function Score

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

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: May 22, 2026
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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