RECRUITINGINTERVENTIONAL

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

A Randomized Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. aged between 50 and 80; 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; Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. aged between 50 and 80; 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: 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.

Treatments Being Tested

DEVICE

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.

DEVICE

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.

DEVICE

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.

Locations (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong