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

Not Applicable

Recruiting

• Conditions: Spinal Cord Injury
• Interventions: Device: Epidural Stimulator

• Registration Number: NCT05433064
• Lead Sponsor: Buddhist Tzu Chi General Hospital

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.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2022-04-17
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epidural Stimulator	Epidural 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.

Primary Outcome Measures

Name	Time	Method
Assessment of volitional movement of lower limbs using electromyographic analysis	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
6-Meter Time Up and Go (6TUG)	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.
Trunk stability measurement (trunk control assessment)	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 Outcome Measures

Name	Time	Method
Change in spasticity as measured by the Modified Ashworth Scale (MAS)	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.
Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score	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.
Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)	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
Change in ability (or inability) to safely balance as measured by the Berg Balance Scale (BBS)	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.

Trial Locations

Locations (1)

Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital; 🇨🇳 Hualien City, Taiwan