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NCT Number: NCT06455137

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

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

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+886-3-856-1825 ext. 13054

Yu-Chen Chen

CONTACT

[email protected]

+886-3-856-1825 ext. 13054

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 12, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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