StrokeNCT05981989
Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
A study testing Epidural electrical stimulation (EES) in people with Stroke, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Epidural electrical stimulation (EES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
Hualien City, 970
Sheng-Tzung Tsai, M.D., Ph.D., +886-3-856-1825 ext. 13054, flydream.tsai@gmail.com
Yu-Chen Chen, M.D., Ph.D., +886-3-856-1825 ext. 13054, spring810569@gmail.com
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Epidural electrical stimulation (EES)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Epidural electrical stimulation (EES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Secondary outcomes (2)
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
Measured: 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.
Measured: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheng-Tzung Tsai, M.D., Ph.D., Principal investigator, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981989
- Sponsor's protocol ID
- IRB112-125-A
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
- ClinicalTrials.gov ID
- NCT05981989
- Acronym / sponsor ID
- IRB112-125-A
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural electrical stimulation (EES) | Experimental | Device: Epidural electrical stimulation (EES)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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Epidural electrical stimulation (EES) |
Primary outcome
Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA)
Time frame: 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: 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.
2 secondary outcomes
Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
Change in spasticity as measured by the Modified Ashworth Scale (MAS)
Time frame: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheng-Tzung Tsai, M.D., Ph.D. principal investigator
Hualien Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural electrical stimulation (EES) in people with Stroke, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Tzung Tsai, M.D., Ph.D. (+886-3-856-1825 ext. 13054, flydream.tsai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA) (time frame: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.