Epidural electrical stimulation (EES): 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.
Study 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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
Hualien City
Taiwan
Recruiting
More Buddhist Tzu Chi General Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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