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Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain

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ClinicalTrials.gov Identifier: NCT05981989
Recruitment Status : Recruiting
First Posted : August 8, 2023
Last Update Posted : August 8, 2023
Sponsor:
Information provided by (Responsible Party):
Buddhist Tzu Chi General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Device: Epidural electrical stimulation (EES) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05981989


Contacts
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Contact: Sheng-Tzung Tsai, M.D., Ph.D. +886-3-856-1825 ext 13054 flydream.tsai@gmail.com
Contact: Yu-Chen Chen, M.D., Ph.D. +886-3-856-1825 ext 13054 spring810569@gmail.com

Locations
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Taiwan
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital Recruiting
Hualien City, Taiwan, 970
Contact: Sheng-Tzung Tsai, M.D., Ph.D.    +886-3-856-1825 ext 13054    flydream.tsai@gmail.com   
Contact: Yu-Chen Chen, M.D., Ph.D.    +886-3-856-1825 ext 13054    spring810569@gmail.com   
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Principal Investigator: Sheng-Tzung Tsai, M.D., Ph.D. Hualien Tzu Chi General Hospital
More Information
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Responsible Party: Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT05981989    
Other Study ID Numbers: IRB112-125-A
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: July 2023

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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
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases