Clinical trial NCT05615610: Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
Official title: A Randomized Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 electrical nerve stimulation (TENS) applied on thoracic region 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 TENS and tVNS on cognitive function in people with stroke. Therefore, the purpose of this study is to evaluate the effectiveness of TENS on improving upper limb function and cognitive function in people with chronic stroke. Also, this study will investigate the cortical response of people with stroke during TENS by using EEG power spectrum analysis.

Detailed description: This study aims to investigate the effects of three intervention protocols in people with stroke. The participants in Group A will receive TENS on C6 and T5 level of the spine with upper limb exercises. The participants in Group B will receive tVNS on the cymba conchae of left outer ear with upper limb exercises. The participants in Group C will receive placebo tVNS with upper limb exercises.

Eligibility criteria: Inclusion Criteria:

1. aged between 50 and 80;
2. have suffered from a single stroke at least 1 year;
3. had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder;
4. scored 7 or above in the Abbreviated Mental Test.

Exclusion Criteria:

1. have cardiac pacemaker or cochlear implant;
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.

Primary outcomes:
measure: Fugl-Meyer Assessment of the Upper Extremity
timeFrame: Baseline (0 week)
measure: Fugl-Meyer Assessment of the Upper Extremity
timeFrame: Mid-intervention (3 week)
measure: Fugl-Meyer Assessment of the Upper Extremity
timeFrame: Post-intervention (6 week)
measure: Fugl-Meyer Assessment of the Upper Extremity
timeFrame: 1-month follow-up (10 week)
measure: Wolf Motor Function Test
timeFrame: Baseline (0 week)
measure: Wolf Motor Function Test
timeFrame: Mid-intervention (3 week)
measure: Wolf Motor Function Test
timeFrame: Post-intervention (6 week)
measure: Wolf Motor Function Test
timeFrame: 1-month follow-up (10 week)
measure: Muscle strength
timeFrame: Baseline (0 week)
measure: Muscle strength
timeFrame: Mid-intervention (3 week)
measure: Muscle strength
timeFrame: Post-intervention (6 week)
measure: Muscle strength
timeFrame: 1-month follow-up (10 week)
measure: Muscle stiffness
timeFrame: Baseline (0 week)
measure: Muscle stiffness
timeFrame: Mid-intervention (3 week)
measure: Muscle stiffness
timeFrame: Post-intervention (6 week)
measure: Muscle stiffness
timeFrame: 1-month follow-up (10 week)
measure: Rivermead Behavioural Memory Test - Third edition
timeFrame: Baseline (0 week)
measure: Rivermead Behavioural Memory Test - Third edition
timeFrame: Mid-intervention (3 week)
measure: Rivermead Behavioural Memory Test - Third edition
timeFrame: Post-intervention (6 week)
measure: Rivermead Behavioural Memory Test - Third edition
timeFrame: 1-month follow-up (10 week)
measure: Digit Span Test
timeFrame: Baseline (0 week)
measure: Digit Span Test
timeFrame: Mid-intervention (3 week)
measure: Digit Span Test
timeFrame: Post-intervention (6 week)
measure: Digit Span Test
timeFrame: 1-month follow-up (10 week)
measure: Montreal Cognitive Assessment
timeFrame: Baseline (0 week)
measure: Montreal Cognitive Assessment
timeFrame: Mid-intervention (3 week)
measure: Montreal Cognitive Assessment
timeFrame: Post-intervention (6 week)
measure: Montreal Cognitive Assessment
timeFrame: 1-month follow-up (10 week)
measure: Trail Making Test
timeFrame: Baseline (0 week)
measure: Trail Making Test
timeFrame: Mid-intervention (3 week)
measure: Trail Making Test
timeFrame: Post-intervention (6 week)
measure: Trail Making Test
timeFrame: 1-month follow-up (10 week)
measure: Oxford Participation and Activities Questionnaire
timeFrame: Baseline (0 week)
measure: Oxford Participation and Activities Questionnaire
timeFrame: Mid-intervention (3 week)
measure: Oxford Participation and Activities Questionnaire
timeFrame: Post-intervention (6 week)
measure: Oxford Participation and Activities Questionnaire
timeFrame: 1-month follow-up (10 week)
measure: 12-item Short-Form Survey (second version)
timeFrame: Baseline (0 week)
measure: 12-item Short-Form Survey (second version)
timeFrame: Mid-intervention (3 week)
measure: 12-item Short-Form Survey (second version)
timeFrame: Post-intervention (6 week)
measure: 12-item Short-Form Survey (second version)
timeFrame: 1-month follow-up (10 week)
measure: Arm Activity Measure
timeFrame: Baseline (0 week)
measure: Arm Activity Measure
timeFrame: Mid-intervention (3 week)
measure: Arm Activity Measure
timeFrame: Post-intervention (6 week)
measure: Arm Activity Measure
timeFrame: 1-month follow-up (10 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Shamay NG, PhD
role: PRINCIPAL_INVESTIGATOR
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