Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 15, 2025 → Dec 15, 2026
See other at-risk trials from The Hong Kong Polytechnic University

Record History

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  1. Notable Primary and study completion pushed from Dec 15, 2025 to Dec 15, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 36 of 36 entries
    • Publications: details revised at 33 of 35 entries
  2. Minor Secondary endpoints: details revised at 4 of 36 entriesv6
  3. Notable Primary and study completion dates: Dec 1, 2024 to Dec 15, 2025v5 Show 7 more changesShow less
    • Start date: Dec 1, 2022 to Nov 1, 2023
    • Primary endpoints: 44 to 8
    • Enrollment target: 75 to 90
    • Interventions: Control (Device), spine TENS (Device), tVNS (Device) to Control (Device), tSCS (Device), tVNS (Device)
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints expanded, about 136 words
    • Study description revised
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 1, 2023 to Dec 1, 2024
    • Primary endpoints: 37 to 44
    • Site details revised
    v3
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • 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 impairment is present in more than 85% of people with stroke, which greatly affect the quality of life, social participation, and performance of daily activities of people with stroke. Previous study also revealed that 53.4% of people after stroke experienced cognitive impairment. Different cognitive domains might be affected following stroke, such as attention, memory, language, and orientation, and the problems with memory are often prominent. Yet, there is no effective treatment for the post-stroke cognitive impairment. Transcutaneous spinal cord stimulation (tSCS) and transcutaneous vagus nerve stimulation (tVNS) are simple and non-invasive treatment to improve upper limb motor function and cognitive function. However, no existing studies have explored on the effects of tSCS and tVNS on cognitive function in people with stroke. Therefore, the purpose of this study is to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) on improving upper limb function and cognitive function in people with chronic stroke.
Trial Details
NCT Number NCT05615610
Lead Sponsor The Hong Kong Polytechnic University
Conditions
(from sponsor)
Chronic Stroke
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov