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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05433064
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
Buddhist Tzu Chi General Hospital

Study Description
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Brief Summary:
The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Epidural Stimulator Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation for Spinal Cord Injury Patients - Regain Walk and Alleviate Pain
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.
Other Name: Abbott Lead-3219


Outcome Measures
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Primary Outcome Measures :
  1. 6-Meter Time Up and Go (6TUG) [ Time Frame: 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.

  2. Assessment of volitional movement of lower limbs using electromyographic analysis [ Time Frame: 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

  3. Trunk stability measurement (trunk control assessment) [ Time Frame: 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 :
  1. Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF) [ Time Frame: 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

  2. Change in spasticity as measured by the Modified Ashworth Scale (MAS) [ Time Frame: 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.

  3. Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score [ Time Frame: 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.

  4. Change in ability (or inability) to safely balance as measured by the Berg Balance Scale (BBS) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05433064


Contacts
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Contact: Sheng-Tzung Tsai, M.D., Ph.D. +886-3-856-1825 ext 13054 flydream.tsai@gmail.com
Contact: Yu-Chen Chen +886-3-856-1825 ext 13054 spring810569@gmail.com

Locations
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Taiwan
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital Recruiting
Hualien City, Taiwan, 970
Contact: Sheng-Tzung Tsai    +886-3-856-1825 ext 13054    flydream.tsai@gmail.com   
Contact: Yu-Chen Chen    +886-3-856-1825    spring810569@gmail.com   
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Principal Investigator: Sheng-Tzung Tsai, M.D., Ph.D. Hualien Tzu Chi General Hospital
More Information
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Responsible Party: Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT05433064    
Other Study ID Numbers: TCMF-EP 110-02(111)
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System