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

NCT05433064 | Recruiting FDA Device

• 1 other identifier: TCMF-EP 110-02(111)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• 6-Meter Time Up and Go (6TUG)

  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

  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)

  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 Outcomes (4)

• Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)

  Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation

• Change in spasticity as measured by the Modified Ashworth Scale (MAS)

  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

  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)

  Baseline; 7 months after implant

Study Arms (1)

Epidural Stimulator

EXPERIMENTAL

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

Interventions

Epidural Stimulator DEVICE

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.

Also known as: Abbott Lead-3219

Epidural Stimulator

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, Taiwan, 970, Taiwan

RECRUITING

Related Publications (2)

• Wu MY, Chen LH, Yang CH, Wu CC, Huang XL, Yan LC, Lin SZ, Wang PK, Lee CH, Chen YC, Tsai ST. Synergistic effect of epidural electrical stimulation and exoskeleton walk training on dynamic balance for participants with spinal cord injury. J Spinal Cord Med. 2025 Oct 24:1-10. doi: 10.1080/10790268.2025.2574134. Online ahead of print.

  PMID: 41134059 DERIVED

• Chen YC, Huang XL, Cheng HY, Wu CC, Wu MY, Yan LC, Chen SY, Tsai ST, Lin SZ. Role of Epidural Electrode Stimulation in Three Patients with Incomplete AIS D Spinal Cord Injury. Biomedicines. 2025 Jan 10;13(1):155. doi: 10.3390/biomedicines13010155.

  PMID: 39857740 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sheng-Tzung Tsai, M.D., Ph.D.

  Hualien Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+886-3-856-1825; flydream.tsai@gmail.com

Yu-Chen Chen

CONTACT

+886-3-856-1825; spring810569@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: June 27, 2022
• Study Start: May 1, 2020
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)