Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study.
H Nakayama, H S Jørgensen, H O Raaschou...
https://pubmed.ncbi.nlm.nih.gov/8172497Actively Recruiting
Phase Not Applicable
Age: 50Years - 80Years
All Genders
ID05615610
A Randomized Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
Led by The Hong Kong Polytechnic University · Updated on 2025-08-20
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Upper limb impairment affects more than 85% of people who have had a stroke, significantly impacting their quality of life, social activities, and daily tasks. Cognitive impairment after stroke is also common, affecting areas such as attention, memory, language, and orientation, with memory problems often being prominent. There is currently no effective treatment for cognitive impairment following stroke. This research aims to evaluate the effects of transcutaneous electrical nerve stimulation (TENS) on improving both upper limb function and cognitive function in people with chronic stroke. The study compares three intervention groups. Group A will receive transcutaneous spinal cord stimulation (tSCS) at the C6 and T5 spinal levels combined with upper limb exercises. Group B will receive transcutaneous vagus nerve stimulation (tVNS) on the left outer ear's cymba conchae along with upper limb exercises. Group C will receive placebo stimulation with upper limb exercises. Each participant will undergo eighteen 45-minute sessions over six weeks, at three sessions per week. Participants will be evaluated at baseline, mid-intervention (3 weeks), post-intervention (6 weeks), and at a 1-month follow-up (10 weeks). Assessments include the Fugl-Meyer Assessment of the Upper Extremity and the Montreal Cognitive Assessment to measure motor and cognitive function. Secondary tests include the Wolf Motor Function Test, muscle strength and stiffness measurements, memory tests, activity measures, and quality of life surveys. The study monitors changes over time to assess the effectiveness of the interventions.
CONDITIONS
Brief Title
Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
Who Can Participate
Age: 50Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged between 50 and 80 years
- Have had a single stroke at least 6 months ago
- Have voluntary control of the non-paretic arm and minimal anti-gravity movement in the paretic shoulder
You will not qualify if you...
- Have a cardiac pacemaker or cochlear implant
- Have other neurological diseases
- Are taking medications that may affect study outcomes
- Have skin lesions, infections, or inflammation near the stimulation sites
- Are currently participating in other drug or treatment programs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 6 weeks
Participants receive one of three intervention protocols: tSCS on the spine with upper limb exercises, tVNS on the outer ear with upper limb exercises, or placebo stimulation with upper limb exercises.
Eighteen 45-minute sessions, 3 sessions per week
Follow-up
Duration - 4 weeks
Participants are assessed for cognitive and upper limb motor function one month after completing the intervention.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Actively Recruiting
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Research Team
S
Shamay NG, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Stroke rehabilitation.
Peter Langhorne, Julie Bernhardt, Gert Kwakkel
https://pubmed.ncbi.nlm.nih.gov/21571152Factors influencing stroke survivors' quality of life during subacute recovery.
Deborah S Nichols-Larsen, P C Clark, Angelique Zeringue...
https://pubmed.ncbi.nlm.nih.gov/15947263Predictors of long-term participation after stroke.
Johanne Desrosiers, Luc Noreau, Annie Rochette...
https://pubmed.ncbi.nlm.nih.gov/16467057Long-term recovery of upper limb motor function and self-reported health: results from a multicenter observational study 1 year after discharge from rehabilitation.
Thies Ingwersen, Silke Wolf, Gunnar Birke...
https://pubmed.ncbi.nlm.nih.gov/34955097Systematic Review and Meta-Analysis of Prevalence in Post-Stroke Neurocognitive Disorders in Hospital-Based Studies.
Mélanie Barbay, Momar Diouf, Martine Roussel...
https://pubmed.ncbi.nlm.nih.gov/30504699Cognitive impairment and memory dysfunction after a stroke diagnosis: a post-stroke memory assessment.
Noor Kamal Al-Qazzaz, Sawal Hamid Ali, Siti Anom Ahmad...
https://pubmed.ncbi.nlm.nih.gov/25228808Post-stroke cognitive impairment: epidemiology, mechanisms and management.
Jia-Hao Sun, Lan Tan, Jin-Tai Yu
https://pubmed.ncbi.nlm.nih.gov/25333055Reliability and validity of the abbreviated mental test (Hong Kong version) in residential care homes.
Simon C Lam, Yuet-Ying Wong, Jean Woo
https://pubmed.ncbi.nlm.nih.gov/21054326Effects of transcutaneous electrical nerve stimulation on memory and behavior in Alzheimer's disease may be stage-dependent.
E J Scherder, A Bouma
https://pubmed.ncbi.nlm.nih.gov/10188004