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This study aims to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the upper limbs in people with hemiplegia following a stroke.
The purpose of this study is to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. Participants will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, Participants will undergo a structured physical rehabilitation program and electrical stimulation. Researchers will quantify the motor potentials in the arm and hand muscles generated by EES of the cervical spinal cord, tune optimal stimulation parameters to induced arm and hand movement, and assess participant motor function of the upper limb with standard clinical tests and simple motor tasks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural electrical stimulation (EES) | Experimental | Subjects will be implanted with 16-electrode epidural array in the C6-T1 area of the spinal cord. After surgery, subjects will undergo a structured program of physical rehabilitation and electrical stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural electrical stimulation (EES) | Device | Subjects will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, subjects will undergo a structured physical rehabilitation program and electrical stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA) | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is main assesses motor functioning and sensation in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and plan and assess treatment. The upper extremity motor function score ranges from 0 to 66. | Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation |
| Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT) | Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function. | Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF) | The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". , The higher the score, the better the quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng-Tzung Tsai, M.D., Ph.D. | Contact | +886-3-856-1825 | 13054 | flydream.tsai@gmail.com |
| Yu-Chen Chen, M.D., Ph.D. | Contact | +886-3-856-1825 | 13054 | spring810569@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheng-Tzung Tsai, M.D., Ph.D. | Hualien Tzu Chi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital | Recruiting | Hualien City | 970 | Taiwan |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation |
| Change in spasticity as measured by the Modified Ashworth Scale (MAS) | Quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow, and wrist. The muscle tension is divided into 0-4 grades. The lower the score, the closer to normal. The higher the score, the more severe the spasticity. | Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |