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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433064
• Other study ID #: TCMF-EP 110-02(111)
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Buddhist Tzu Chi General Hospital
• Contact: Sheng-Tzung Tsai, M.D., Ph.D.
• Phone: +886-3-856-1825
• Email: flydream.tsai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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