RecruitingNot ApplicableNCT05433064

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


Sponsor

Buddhist Tzu Chi General Hospital

Enrollment

12 participants

Start Date

May 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 20 YearsMax Age: 70 Years

Inclusion Criteria8

  • 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 Criteria8

  • 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.

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Interventions

DEVICEEpidural 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.


Locations(1)

Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, Taiwan, Taiwan

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NCT05433064


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