Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement

September 16, 2025 updated by: Buddhist Tzu Chi General Hospital
The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is for the treatment of spinal cord injury (SCI) paralysis patients use the signal by electrophysiological analysis of epidural spinal cord stimulation (SCS) settings that promote limbs activity so that SCI patients can restore motor ability under multiple sensory stimuli and multimodal electrical stimulation rehabilitation. The investigators hope to establish an atresia nerve regulation strategy and observe that the original blocked neural circuits can improve nerve plasticity by SCS. Even can establish new connections through residual nerves and allow SCI patients to rebuild neural circuits without SCS to restore limbs mobility and improve quality of life.

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, 970
        • Recruiting
        • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
        • Contact:
        • 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:

  • SCI ASIA: A, B, C,D
  • Between 20 and 70 year of age
  • >1 year post SCI
  • Complete or incomplete spinal cord injury.
  • Expected will undergo spinal cord stimulation surgery.
  • Continued rehabilitation after surgery for spinal cord injury.
  • Able to comply with procedures and follow up.
  • Stable medical condition without cardiopulmonary disease or dysautonomia that would - contraindicate participation in lower extremity rehabilitation or testing activities

Exclusion Criteria:

  • Have significant cognitive impairment (MMSE<24).
  • Had a mental illness within one year or been treated in the past.
  • Have Major depressive disorder.
  • Active cancer diagnosis.
  • Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training.
  • Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
  • Unable to read and/or comprehend the consent form.
  • Have concerns about this trial and do not sign consent.

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 Stimulator
Participants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation.
Device: Epidural Stimulator
Participants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography and Electromyography
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To measure activity in the brain
To measure assessing change between pre-implant and every 3 months until 24 months.
Electromyographic analysis
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Average of 5-repetitive EMG activity for each superficial component of muscles from a five-second ramp contraction to the end of a ten-second rest
To measure assessing change between pre-implant and every 3 months until 24 months.
Single transcranial magnetic stimulation
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To evaluate the function of corticospinal tract nerve conduction
To measure assessing change between pre-implant and every 3 months until 24 months.
Motion Analysis
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To evaluate the angles that can be achieved at each joint of the upper limbs
To measure assessing change between pre-implant and every 3 months until 24 months.
Functional Test
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To evaluate gait for subjects who can walk by assistive device or independently
To measure assessing change between pre-implant and every 3 months until 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To measure performance in activities of daily living
To measure assessing change between pre-implant and every 3 months until 24 months.
World Health Organization Quality of Life Brief Version
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
A brief version scale of World Health Organization Quality-of-Life scale
To measure assessing change between pre-implant and every 3 months until 24 months.
Spinal Cord Independence Measure
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To measure performance in activities of daily living and mobility
To measure assessing change between pre-implant and every 3 months until 24 months.
Box and Block Test
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To measure unilateral gross manual dexterity.
To measure assessing change between pre-implant and every 3 months until 24 months.
Action Research Arm Test Scoring Sheet
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To measures upper limb function by scoring the ability to complete functional tasks.
To measure assessing change between pre-implant and every 3 months until 24 months.
Walking Index for Spinal Cord Injury II (WISCI II- March 2005)
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To measure walking ability for spinal cord injury.
To measure assessing change between pre-implant and every 3 months until 24 months.
American Spinal Injury Association (ASIA-2019) Impairment Scale
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.

To measure and record disease history

In simpler terms, it's a 5-point scale that categorizes individuals from "A" (complete spinal cord injury) to "E" (normal sensory and motor function), with each letter representing a different level of injury severity:

A: Complete spinal cord injury. B: Sensory incomplete injury. C: Motor incomplete injury. D: Motor incomplete injury. E: Normal sensory and motor function.
To measure assessing change between pre-implant and every 3 months until 24 months.
Modified Ashworth scale
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To measure the increase of muscle tone,it uses a 6-point system. Scores range from 0 to 4. Lower scores indicate normal muscle tone, while higher scores indicate spasticity or increased resistance to passive movement.
To measure assessing change between pre-implant and every 3 months until 24 months.
Berg Balance Scale
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To measure balance and the risk of falls,it's a list of 14 things to rate, where each thing has a scale from 0 to 4. Zero means the lowest function, while four means the highest function.
To measure assessing change between pre-implant and every 3 months until 24 months.

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)

April 30, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB112-067-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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