Stroke
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Between 20 and 70 years of age * First-ever clinical manifest stroke * Right or left hemiparesis * Scores higher than 7 and lower than 45 on the Fugl-Meyer scale. * Expected will undergo spinal cord stimulation surgery. * Able to comply with procedures and follow up. * Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities.
Exclusion criteria
* Pregnancy or breast feeding. * Have Major depressive disorder. * Had a mental illness within one year or been treated in the past. * Have significant cognitive impairment (MMSE\<24) or serious disease that could affect the ability to participate in study activities. * Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention. * Receiving anticoagulant, anti-spasticity or anti-epileptic medications prior to or throughout the duration of the study. * Unable to read and/or comprehend the consent form. * Have concerns about this trial and do not sign consent. * Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA) | Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation | 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. |
| Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT) | Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF) | Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation | 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 |
| Change in spasticity as measured by the Modified Ashworth Scale (MAS) | Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation | 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. |
Countries
Taiwan
Contacts
Primary ContactSheng-Tzung Tsai, M.D., Ph.D.
Backup ContactYu-Chen Chen, M.D., Ph.D.
Outcome results
None listed