Back to resultsEpidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Epidural electrical stimulation (EES)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility 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.
Sites / Locations
- Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epidural electrical stimulation (EES)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT05981989
First Posted
August 1, 2023
Last Updated
August 1, 2023
Sponsor
Buddhist Tzu Chi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05981989
Brief Title
Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
Official Title
Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epidural electrical stimulation (EES)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Epidural electrical stimulation (EES)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA)
Description
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
Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Title
Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
Description
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
Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Secondary Outcome Measure Information:
Title
Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)
Description
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
Time Frame
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
Title
Change in spasticity as measured by the Modified Ashworth Scale (MAS)
Description
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
Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Tzung Tsai, M.D., Ph.D.
Phone
+886-3-856-1825
Ext
13054
Email
flydream.tsai@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Chen Chen, M.D., Ph.D.
Phone
+886-3-856-1825
Ext
13054
Email
spring810569@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Tzung Tsai, M.D., Ph.D.
Organizational Affiliation
Hualien Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Tzung Tsai, M.D., Ph.D.
Phone
+886-3-856-1825
Ext
13054
Email
flydream.tsai@gmail.com
First Name & Middle Initial & Last Name & Degree
Yu-Chen Chen, M.D., Ph.D.
Phone
+886-3-856-1825
Ext
13054
Email
spring810569@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
We'll reach out to this number within 24 hrs