Menu
Recruiting NCT06455137

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

No phase Interventional Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epidural Stimulator.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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.

Interventions

  • Device Epidural Stimulator
    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 outcome measures

  • Electroencephalography and Electromyography [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Electromyographic analysis [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Single transcranial magnetic stimulation [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Motion Analysis [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Functional Test [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
Secondary outcome measures (9)
  • American Spinal Injury Association (ASIA-2019) Impairment Scale [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Modified Ashworth scale [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Barthel Index [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • World Health Organization Quality of Life Brief Version [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Spinal Cord Independence Measure [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Box and Block Test [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Action Research Arm Test Scoring Sheet [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Berg Balance Scale [Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City

Identifiers

NCT: NCT06455137 · IRB112-067-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗