Epidural electrical stimulation to improve movement and reduce pain in stroke patients
Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
This study is testing if a new device that uses electrical stimulation in the spine can help stroke patients regain movement and reduce pain in their arms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Buddhist Tzu Chi General Hospital Academic / other |
| Locations | 1 site (Hualien City) |
| Trial ID | NCT05981989 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of epidural electrical stimulation (EES) on the cervical spinal cord to activate upper limb muscles in individuals with hemiplegia due to stroke. Participants will undergo a surgical procedure to implant an EES system, followed by a structured rehabilitation program that includes electrical stimulation. Researchers will measure the motor potentials generated by EES and optimize stimulation parameters to enhance arm and hand movement. The study will also assess motor function using standard clinical tests and simple motor tasks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 70 who have experienced their first stroke and have hemiparesis with specific Fugl-Meyer scale scores.
Not a fit: Patients with significant cognitive impairment, major depressive disorder, or other serious health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor and sensory function in stroke patients, enhancing their quality of life.
How similar studies have performed: While the use of epidural electrical stimulation is a promising approach, its specific application in stroke rehabilitation is still being explored and may be considered novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hualien City
- Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Sheng-Tzung Tsai, M.D., Ph.D. — Hualien Tzu Chi General Hospital
- Study coordinator: Sheng-Tzung Tsai, M.D., Ph.D.
- Email: flydream.tsai@gmail.com
- Phone: +886-3-856-1825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.