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Recruiting NCT07722429

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

No phase Interventional Spinal Cord Injury(SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epidural electrical stimulation (EES).
Who it may be relevant to
Registry conditions: Spinal Cord Injury(SCI). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
Secondary outcome measures (3)
  • 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]
  • 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]
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City

Identifiers

NCT: NCT07722429 · IRB114-101-A · NSTC 114-2314-B-303-011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗