Exploration of the Effectiveness and Mechanism of Personalized Epidural Electrical Stimulation in Improving Upper Limb Function in Participants With Spinal Cord Injury

July 20, 2026 updated by: Buddhist Tzu Chi General Hospital
This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine whether epidural electrical stimulation (EES) of the cervical spinal cord can activate arm and hand muscles in patients with spinal cord injury. Participants will undergo surgery to implant a system designed for cervical spinal cord EES. Following surgery, they will engage in structured physical rehabilitation and electrical stimulation therapy. Researchers will quantify the motor potentials in arm and hand muscles evoked by cervical EES, adjust stimulation parameters to optimize the elicitation of arm and hand movements, and assess the participants' upper-limb motor function using standard clinical tests and simple motor tasks.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Hualien City, Taiwan
        • Recruiting
        • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 70 years.
  • Duration since spinal cord injury ranging from 1 to 10 years.
  • Spinal cord injury level at or above T4.
  • MRI and/or CT imaging confirms adequate spinal cord decompression and spinal stability.
  • Stable vital signs and no dependence on mechanical ventilation.
  • Stable neurological and psychological status, with no history of neurological deterioration within the past 6 months (e.g., acute worsening of motor or sensory function, new-onset seizures, acute changes in muscle tone, or other neurological symptoms). Participants must be conscious, able to understand, and comply with study instructions. Clinical neurological examinations and imaging findings (MRI or CT) should demonstrate no new abnormalities.
  • Willingness to participate in and comply with rehabilitation programs.
  • Participants who have completed spinal cord electrical stimulation implantation surgery and/or are currently undergoing conventional rehabilitation therapy.

Exclusion Criteria:

  • Patients with untreated fractures of the upper extremities.
  • Patients with severe skin lesions or wounds that interfere with EMG electrode placement or the surgical sites for electrical stimulation implantation (e.g., chest/back, upper extremities, posterior cervical region, or subclavicular area).
  • Patients with a history of other neurological diseases.
  • Patients with known allergy or hypersensitivity to silver (Ag).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidural electrical stimulation (EES)
Participants will undergo implantation of a 16-electrode epidural spinal cord array. Following surgery, they will participate in a structured program of physical rehabilitation combined with epidural 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III)
Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The Spinal Cord Independence Measure III (SCIM-III) is a standardized functional assessment tool specifically designed for individuals with spinal cord injury. It evaluates independence in daily activities, including self-care, respiration and sphincter management, and mobility, to quantify the impact of spinal cord injury on functional ability. The SCIM-III consists of 19 items, with higher scores indicating greater independence in activities of daily living.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in neurological level of injury as determined by motor and sensory function assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized tool for assessing neurological impairment after spinal cord injury. It evaluates motor and sensory functions to determine the neurological level of injury and classify injury severity using the ASIA Impairment Scale (AIS), ranging from Grade A (complete injury) to Grade E (normal function).
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)
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.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in hand dexterity as measured by the Box and Block Test (BBT).
Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The Box and Block Test (BBT) assesses manual dexterity and upper extremity function by measuring the number of blocks transferred within 60 seconds. Higher scores indicate better hand function and coordination.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
Change in spasticity as measured by the Modified Ashworth Scale (MAS)
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.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in activities of daily living as measured by the Barthel Index (BI).
Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The Barthel Index (BI) assesses functional independence in activities of daily living across 10 domains, including self-care, mobility, and continence. Scores range from 0 to 100, with higher scores indicating greater independence.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Investigators

  • Principal Investigator: Sheng-Tzung Tsai, M.D., Ph.D, Hualien Tzu Chi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB114-101-A
  • NSTC 114-2314-B-303-011 (Other Grant/Funding Number: National Science and Technology Council, R.O.C)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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