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High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 31, 2026 → Aug 31, 2027
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from National Taiwan University Hospital

Record History

  1. Notable Primary completion pushed from Aug 31, 2026 to Aug 31, 2027 Primary endpoint(s) modified · Completion pushed from Nov 30, 2026 to Nov 30, 2027 · Secondary endpoints revised (5) · 1 morev3 Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Completion pushed from Nov 30, 2026 to Nov 30, 2027
    • Secondary endpoints revised (5)
    • Study sites revised (3)

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 1, 2024 to Aug 15, 2024 · Site details revised at 3 of 3 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jun 1, 2024 to Aug 15, 2024
    • Site details revised at 3 of 3 sites
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06409143
Lead Sponsor National Taiwan University Hospital
Conditions Stroke
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov