Clinical trial NCT06455137: Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement
Official title: Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Electroencephalography and Electromyography
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Electromyographic analysis
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Single transcranial magnetic stimulation
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Motion Analysis
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Functional Test
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary outcomes:
measure: American Spinal Injury Association (ASIA-2019) Impairment Scale
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Modified Ashworth scale
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Barthel Index
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: World Health Organization Quality of Life Brief Version
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Spinal Cord Independence Measure
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Box and Block Test
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Action Research Arm Test Scoring Sheet
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Berg Balance Scale
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Walking Index for Spinal Cord Injury II (WISCI II- March 2005)
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
Study officials:
affiliation: Hualien Tzu Chi General Hospital
name: Sheng-Tzung Tsai, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: