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

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Epidural Stimulator
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epidural Stimulator

Arm Description

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.

Outcomes

Primary Outcome Measures

6-Meter Time Up and Go (6TUG)
To evaluate gait for subjects who can walk by assistive device or independently.
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
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.

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
April 17, 2022
Last Updated
September 3, 2022
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05433064
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural Stimulator
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Epidural Stimulator
Other Intervention Name(s)
Abbott Lead-3219
Intervention Description
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 Measure Information:
Title
6-Meter Time Up and Go (6TUG)
Description
To evaluate gait for subjects who can walk by assistive device or independently.
Time Frame
To measure assessing change between pre-implant and every 3 months until 24 months.
Title
Assessment of volitional movement of lower limbs using electromyographic analysis
Description
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
Time Frame
To measure assessing change between pre-implant and every 3 months until 24 months.
Title
Trunk stability measurement (trunk control assessment)
Description
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.
Time Frame
To measure assessing change between pre-implant and every 3 months until 24 months.]
Secondary Outcome Measure Information:
Title
Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)
Description
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
Time Frame
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
Title
Change in spasticity as measured by the Modified Ashworth Scale (MAS)
Description
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.
Time Frame
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Title
Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score
Description
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.
Time Frame
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
Title
Change in ability (or inability) to safely balance as measured by the Berg Balance Scale (BBS)
Description
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.
Time Frame
Baseline; 7 months after implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Tzung Tsai, M.D., Ph.D.
Phone
+886-3-856-1825
Ext
13054
Email
flydream.tsai@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Chen Chen
Phone
+886-3-856-1825
Ext
13054
Email
spring810569@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Tzung Tsai, M.D., Ph.D.
Organizational Affiliation
Hualien Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Tzung Tsai
Phone
+886-3-856-1825
Ext
13054
Email
flydream.tsai@gmail.com
First Name & Middle Initial & Last Name & Degree
Yu-Chen Chen
Phone
+886-3-856-1825
Email
spring810569@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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