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NCT06409143 · ClinicalTrials.gov record · last posted 2026-08-20

High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

StatusRecruiting
PhaseNot applicable
Started2024-08-15
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-21
critical
Primary endpoint(s) modified
WasPre- and 3-month change in motor function of the upper limbs assessed by Action Research Arm Test (ARAT), Pre- and 3-month change in motor function of the upper limbs assessed by Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
NowPre- and 1-month change in motor function of the upper limbs assessed by Action Research Arm Test (ARAT), Pre- and 1-month change in motor function of the upper limbs assessed by Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
2026-08-21
critical
Primary completion pushed: 2026-08-31 → 2027-08-31
2026-08-21
minor
Completion pushed: 2026-11-30 → 2027-11-30
Trial Details
NCT Number NCT06409143
Lead Sponsor National Taiwan University Hospital
Conditions Stroke
Enrollment 152 participants
Start Date 2024-08-15
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-20