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

NCT05615610 | Recruiting

• 1 other identifier: 2022_TVNS_STROKE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (8)

• Fugl-Meyer Assessment of the Upper Extremity

  The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) assesses the motor control, which included the reflex, synergistic and isolated movements and coordination of the upper extremity. It is a 3-point ordinal scale with 33 items and the total score ranges from 0 to 66. In this scale, "0" represents "cannot perform", "1" represents "performs partially" and "2" represents "performs fully". The higher score indicates better motor control of the upper extremity. The FMA-UE has an excellent inter-rater reliability (ICC = 0.98) in people with stroke.

  Baseline (0 week)

• Fugl-Meyer Assessment of the Upper Extremity

  The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) assesses the motor control, which included the reflex, synergistic and isolated movements and coordination of the upper extremity. It is a 3-point ordinal scale with 33 items and the total score ranges from 0 to 66. In this scale, "0" represents "cannot perform", "1" represents "performs partially" and "2" represents "performs fully". The higher score indicates better motor control of the upper extremity. The FMA-UE has an excellent inter-rater reliability (ICC = 0.98) in people with stroke.

  Mid-intervention (3 week)

• Fugl-Meyer Assessment of the Upper Extremity

  The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) assesses the motor control, which included the reflex, synergistic and isolated movements and coordination of the upper extremity. It is a 3-point ordinal scale with 33 items and the total score ranges from 0 to 66. In this scale, "0" represents "cannot perform", "1" represents "performs partially" and "2" represents "performs fully". The higher score indicates better motor control of the upper extremity. The FMA-UE has an excellent inter-rater reliability (ICC = 0.98) in people with stroke.

  Post-intervention (6 week)

• Fugl-Meyer Assessment of the Upper Extremity

  The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) assesses the motor control, which included the reflex, synergistic and isolated movements and coordination of the upper extremity. It is a 3-point ordinal scale with 33 items and the total score ranges from 0 to 66. In this scale, "0" represents "cannot perform", "1" represents "performs partially" and "2" represents "performs fully". The higher score indicates better motor control of the upper extremity. The FMA-UE has an excellent inter-rater reliability (ICC = 0.98) in people with stroke.

  1-month follow-up (10 week)

• Montreal Cognitive Assessment

  The Montreal Cognitive Assessment (MoCA) is a screening tool to detect cognitive impairment of an individual with a total score of 30. The MoCA assesses different cognitive domains, including executive functioning, immediate and delayed memory, visuospatial abilities, attention, working memory, language, and orientation to time and place. It can identify dementia from controls with a sensitivity of 92.3% and specificity of 91.8% with a cut-off score of 22.

  Baseline (0 week)

• Montreal Cognitive Assessment

  The Montreal Cognitive Assessment (MoCA) is a screening tool to detect cognitive impairment of an individual with a total score of 30. The MoCA assesses different cognitive domains, including executive functioning, immediate and delayed memory, visuospatial abilities, attention, working memory, language, and orientation to time and place. It can identify dementia from controls with a sensitivity of 92.3% and specificity of 91.8% with a cut-off score of 22.

  Mid-intervention (3 week)

• Montreal Cognitive Assessment

  The Montreal Cognitive Assessment (MoCA) is a screening tool to detect cognitive impairment of an individual with a total score of 30. The MoCA assesses different cognitive domains, including executive functioning, immediate and delayed memory, visuospatial abilities, attention, working memory, language, and orientation to time and place. It can identify dementia from controls with a sensitivity of 92.3% and specificity of 91.8% with a cut-off score of 22.

  Post-intervention (6 week)

• Montreal Cognitive Assessment

  The Montreal Cognitive Assessment (MoCA) is a screening tool to detect cognitive impairment of an individual with a total score of 30. The MoCA assesses different cognitive domains, including executive functioning, immediate and delayed memory, visuospatial abilities, attention, working memory, language, and orientation to time and place. It can identify dementia from controls with a sensitivity of 92.3% and specificity of 91.8% with a cut-off score of 22.

  1-month follow-up (10 week)

Secondary Outcomes (36)

• Wolf Motor Function Test

  Baseline (0 week)

• Wolf Motor Function Test

  Mid-intervention (3 week)

• Wolf Motor Function Test

  Post-intervention (6 week)

• Wolf Motor Function Test

  1-month follow-up (10 week)

• Muscle strength

  Baseline (0 week)

Study Arms (3)

tSCS

EXPERIMENTAL

The participants will be received eighteen 45-minute sessions of intervention, 3 sessions per week for 6 weeks.

Device: tSCS

tVNS

EXPERIMENTAL

The participants will be received eighteen 45-minute sessions of intervention, 3 sessions per week for 6 weeks.

Device: tVNS

Control

PLACEBO COMPARATOR

The participants will be received eighteen 45-minute sessions of intervention, 3 sessions per week for 6 weeks.

Device: Control

Interventions

tSCS DEVICE

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.

tSCS

tVNS DEVICE

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.

tVNS

Control DEVICE

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.

Control

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 50 and 80;
• have suffered from a single stroke at least 6 months;
• had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder;

You may not qualify if:

• have cardiac pacemaker or cochlear implant;
• have other neurological diseases;
• are taking medication that may affect measured outcomes;
• have skin lesions, infection, or inflammation near selected position;
• are participating in other drug/treatment programs.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Related Publications (34)

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  PMID: 41397750 DERIVED

Study Officials

• Shamay NG, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shamay NG, PhD

CONTACT

+852 27664889; shamay.ng@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: November 1, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following publication.
• Access Criteria: IPD of this study will be available upon reasonable request. Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose will be able to access the IPD. IPD meta-analysis will be qualified for data sharing. A proposal that describes planned analyses should be directed to the corresponding author (shamay.ng@polyu.edu.hk).

Locations

HK (1)