Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
NCT ID: NCT05615610
Last Updated: 2025-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-11-01
2025-12-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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tSCS
The participants will be received eighteen 45-minute sessions of intervention, 3 sessions per week for 6 weeks.
tSCS
The participants in Group A will receive tSCS (Burst mode, 9 pulses per burst, pulse frequency = 160 Hz, burst frequency = 2 Hz) with upper limb exercises. The electrical stimulation will be generated by the neurostimulator (MH8000P; MEDIHIGHTEC MEDICAL CO., LTD., Taiwan). Two 7.5 × 12.6 cm electrodes will be attached between C6 and T5 level on each side of spinal column and with 2 cm from the spine. Intensity of TENS will be individually selected by the participants according to tolerance levels.
tVNS
The participants will be received eighteen 45-minute sessions of intervention, 3 sessions per week for 6 weeks.
tVNS
The participants in Group B will receive tVNS (pulse frequency = 25Hz, pulse duration = 0.3 ms) on the cymba conchae of left outer ear with upper limb exercises.The electrical stimulation will be generated by the neurostimulator (MH8000P; MEDIHIGHTEC MEDICAL CO., LTD., Taiwan). Intensity of tVNS will be individually selected by the participants according to tolerance levels. Previous studies showed that it was effective to improve the upper limb motor function in people with stroke and cognitive function in people with mild cognitive function.
Control
The participants will be received eighteen 45-minute sessions of intervention, 3 sessions per week for 6 weeks.
Control
The participants in Group C will receive placebo tSCS and tVNS with upper limb exercises, where the stimulation will be delivered by placebo-TENS device with disconnected electrical circuit.
Interventions
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tSCS
The participants in Group A will receive tSCS (Burst mode, 9 pulses per burst, pulse frequency = 160 Hz, burst frequency = 2 Hz) with upper limb exercises. The electrical stimulation will be generated by the neurostimulator (MH8000P; MEDIHIGHTEC MEDICAL CO., LTD., Taiwan). Two 7.5 × 12.6 cm electrodes will be attached between C6 and T5 level on each side of spinal column and with 2 cm from the spine. Intensity of TENS will be individually selected by the participants according to tolerance levels.
tVNS
The participants in Group B will receive tVNS (pulse frequency = 25Hz, pulse duration = 0.3 ms) on the cymba conchae of left outer ear with upper limb exercises.The electrical stimulation will be generated by the neurostimulator (MH8000P; MEDIHIGHTEC MEDICAL CO., LTD., Taiwan). Intensity of tVNS will be individually selected by the participants according to tolerance levels. Previous studies showed that it was effective to improve the upper limb motor function in people with stroke and cognitive function in people with mild cognitive function.
Control
The participants in Group C will receive placebo tSCS and tVNS with upper limb exercises, where the stimulation will be delivered by placebo-TENS device with disconnected electrical circuit.
Eligibility Criteria
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Inclusion Criteria
2. have suffered from a single stroke at least 6 months;
3. had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder;
Exclusion Criteria
2. have other neurological diseases;
3. are taking medication that may affect measured outcomes;
4. have skin lesions, infection, or inflammation near selected position;
5. are participating in other drug/treatment programs.
50 Years
80 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Principal Investigators
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Shamay NG, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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The Hong Kong Polytechnic University
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2022_TVNS_STROKE
Identifier Type: -
Identifier Source: org_study_id
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