Clinical trial NCT05433064: Spinal Cord Stimulation for Spinal Cord Injury Patients - Regain Walk and Alleviate Pain
Official title: Spinal Cord Stimulation for Spinal Cord Injury Patients - Regain Walk and Alleviate Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 12
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 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.

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: 6-Meter Time Up and Go (6TUG)
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Assessment of volitional movement of lower limbs using electromyographic analysis
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.
measure: Trunk stability measurement (trunk control assessment)
timeFrame: To measure assessing change between pre-implant and every 3 months until 24 months.]
Secondary outcomes:
measure: Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
measure: Change in spasticity as measured by the Modified Ashworth Scale (MAS)
timeFrame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
measure: Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score
timeFrame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
measure: Change in ability (or inability) to safely balance as measured by the Berg Balance Scale (BBS)
timeFrame: Baseline; 7 months after implant
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: