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Completed

NCT Number: NCT05433064

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

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, Taiwan, 970

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 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.

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

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2022
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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