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NCT Number: NCT07722429

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

This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.

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Key information

Conditions

Spinal Cord Injury(SCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location status: Recruiting

Location contact

Sheng-Tzung Tsai, M.D., Ph.D

CONTACT

[email protected]

+886-3-856-1825 ext. 13054

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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, Each item is typically scored on a scale ranging from 0 (completely dependent) to 3 (completely independent).with higher scores indicating greater independence in activities of daily living.

  2. Change in ASIA Impairment Scale (AIS) grade 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 assessment of motor and sensory function following spinal cord injury. Neurological impairment is classified using the American Spinal Injury Association (ASIA) Impairment Scale (AIS), which ranges from Grade A (complete injury) to Grade E (normal motor and sensory function). Higher AIS grades indicate better neurological function and less severe neurological impairment.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng-Tzung Tsai, M.D., Ph.D

CONTACT

[email protected]

+886-3-856-1825 ext. 13054

Yu-Chen Chen, M.D., Ph.D.

CONTACT

[email protected]

+886-3-856-1825 ext. 13054

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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