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

NCT06455137 | Recruiting FDA Device

• 1 other identifier: IRB112-067-A
• Study Type: interventional
• Target: 20
• 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 Injuries

Outcome Measures

Primary Outcomes (5)

• Electroencephalography and Electromyography

  To measure activity in the brain

  To measure assessing change between pre-implant and every 3 months until 24 months.

• Electromyographic analysis

  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

  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

  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

  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 Outcomes (9)

• American Spinal Injury Association (ASIA-2019) Impairment Scale

  To measure assessing change between pre-implant and every 3 months until 24 months.

• Modified Ashworth scale

  To measure assessing change between pre-implant and every 3 months until 24 months.

• Barthel Index

  To measure assessing change between pre-implant and every 3 months until 24 months.

• World Health Organization Quality of Life Brief Version

  To measure assessing change between pre-implant and every 3 months until 24 months.

• Spinal Cord Independence Measure

  To measure assessing change between pre-implant and every 3 months until 24 months.

Study Arms (1)

Epidural Stimulator

EXPERIMENTAL

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

Interventions

Epidural Stimulator DEVICE

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.

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, 970, Taiwan

RECRUITING

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: June 7, 2024
• First Posted: June 12, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)