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Recruiting NCT06409143

High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

Trial Parameters

Condition Stroke
Sponsor National Taiwan University Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 152
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-15
Completion 2026-08-31
Interventions
HD-tESSham HD-tESUE rehabilitation

Brief Summary

Upper limb hemiparesis is the most common sequelae in patients, severely impacting their independence and quality of life. Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. It can induces long-term potentiation-like or long-term depression-like effects, thereby modulating the cortical excitability. In recent years, researchers have developed high-definition (HD) devices, which integrate high definition ring electrode configurations and incorporate direct current with theta burst stimulation waveforms. Diverging from traditional transcranial direct current stimulation (tDCS), which applies weak currents (0.5-2 mA) through two large sponge electrodes (25\~35 cm\^2) externally to the scalp for widespread non-specific cortical stimulation, HD-tES employs an array of small-area electrodes (1 cm\^2) to control current distribution over localized cortical regions, thereby enhancing spatial accuracy. However, there is a lack of studies validating the optimal waveform for HD-tES, as well as clinical evidence in subacute stroke populations. The optimal unilateral versus bilateral stimulation modes and their neurological mechanisms for stroke rehabilitation also remain uncertain.

Eligibility Criteria

Inclusion Criteria: \- Sub-Project 1 (Healthy) 1. Adults aged 18 and above. 2. Confirmed right-handedness using the Edinburgh Handedness Inventory. Sub-Project 1 (Post-stroke patients) 1. Aged 18 and above. 2. Diagnosed with stroke. 3. Post-stroke for more than 6 months. 4. Unilateral hemiparesis. Sub-Project 2 (Subacute-stroke patients) 1. Aged 18 and above. 2. Diagnosed with stroke. 3. Stroke occurred between 7 days to 6 months ago. 4. Unilateral hemiparesis. 5. Degree of recovery for proximal and distal movements of the affected upper limb is Brunnstrom stage III to V. 6. No severe muscle spasticity in any segments of the affected upper limb (Modified Ashworth Scale ≤ 2). Exclusion Criteria: \- Sub-Project 1 (Healthy) 1. History of neurological disorders (e.g., stroke, brain tumor, epilepsy), psychiatric disorders (e.g., substance abuse, major depression, schizophrenia, bipolar disorder), or musculoskeletal disorders of the upper limb. 2. Contraindications to transcranial electrical

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