Spinal Cord Stimulation for Spinal Cord Injury Patients - Regain Walk and Alleviate Pain

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 lower limb activity so that SCI patients can restore the ability to stand and walk 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 lower limb mobility and improve quality of life.

Study Type

Interventional

Enrollment (Estimated)

12

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
    • Taiwan
      • Hualien City, Taiwan, 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

20 years to 70 years (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
Subjects will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord. After 2 weeks recovery,patients will undergo a structured program of physical rehabilitation and electrical stimulation.
Device: Epidural Stimulator
Subjects will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord. After 2 weeks recovery,patients will undergo a structured program of physical rehabilitation and electrical stimulation.
Other Names:
  • Abbott Lead-3219

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Meter Time Up and Go (6TUG)
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.
Assessment of volitional movement of lower limbs using electromyographic analysis
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Average of 6-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.
Trunk stability measurement (trunk control assessment)
Time Frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
To assess the sitting and walking dynamic balance by displacing the center of pressure (CoP) from the force plate and the trunk accelerations with a tri-axial accelerometer. The experiment includes sitting and walking.pressure (CoP) from the force plate and the trunk accelerations with tri-axial accelerometer.
To measure assessing change between pre-implant and every 3 months until 24 months.]

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
It is mainly used to assess muscle spasm (spasticity). 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 motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score
Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
The American Spinal Injury Association (ASIA) Standard Neurological Classification of Spinal Cord Injury is a standard method of assessing the neurological status, including motor and sensory evaluations, of a person who has sustained a spinal cord injury.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
Change in ability (or inability) to safely balance as measured by the Berg Balance Scale (BBS)
Time Frame: Baseline; 7 months after implant
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.a 14-item scale.
Baseline; 7 months after implant

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2020

Primary Completion (Actual)

July 31, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 17, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 27, 2022

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

  • TCMF-EP 110-02(111)

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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