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Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
implanted epidural stimulator
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: AIS B SCI diagnosis Beyond 6 months of injury date SCI at a level range of C7-T8 with signs of upper motor neuron injury 18 years or older Height 5'1" to 6'3" Weight 250 lbs or less Sufficient upper extremity strength to manage a stability aide MRI evidence of spared spinal cord neural fibers Exclusion Criteria: Claustrophobia and/or other contraindications to magnetic resonance imaging (MRI) Unstable or symptomatic cardiorespiratory issues, in the opinion of the investigators Recent (within 3 months) history of fracture, contractures, pressure sore, DVT, urinary tract infection, or other infections that might interfere with interventions Contraindications to epidural stimulator implantation surgery Received botox injections into the lower extremities within the past 6 months Pregnancy Cauda Equina injury Any other neurological disorder besides SCI

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Epidural stimulation with PT

    Arm Description

    Stimulation parameters will be optimized for each lower extremity and joint movement. During physical therapy sessions, electrode configurations may be adjusted as needed to optimize stimulation frequencies, and voltage intensity ranges to best enable voluntary control of lower extremity (ankle, knee, and hip) flexion and extension, as well as standing. Intensive physical therapy will consist of 3 visits per week over the course of 6 months directed by a licensed physical therapist with over a decade of experience working with individuals with SCI, and the epidural stimulator will be ON continuously during these sessions. Physical therapy will involve neurorehabilitation to facilitate voluntary lower extremity movement in the presence of stimulation, with the research participants in the supine, seated, and standing positions.

    Outcomes

    Primary Outcome Measures

    International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS)
    International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS) will be used to measure the degree of voluntary motor change. LEMS is conducted with the participant lying supine and five key muscle groups on each side are tested for their ability to contract against gravity and resistance. A zero to five scale is used with a maximum possible score of 25. ISNCSCI motor testing has been shown to have adequate to excellent interrater reliability in individuals with SCI, and is a valid tool for this population

    Secondary Outcome Measures

    The abbreviated World Health Organization Quality of Life (WHOQOL-BREF)
    The abbreviated World Health Organization Quality of Life (WHOQOL-BREF) instrument will be used to measure the degree of participants' perception of change in quality of life after stimulator implantation. The WHOQOL-BREF assesses quality of life within the context of an individual's culture, value systems, personal goals, standards, and concerns. It has been studied and highly recommended for individuals with SCI.

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    July 17, 2023
    Sponsor
    University of Colorado, Denver
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05966896
    Brief Title
    Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury
    Official Title
    Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury: Spared Fibers Proof-of-concept Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This proof-of-concept case series will prospectively use magnetic resonance imaging (MRI) evidence of spared spinal cord neural fibers to guide the selection of 2 research participants to receive a surgically implanted epidural stimulator with the goal of restoring voluntary movement after spinal cord injury (SCI). Because MRI evidence of spared spinal cord neural fibers demonstrated significant relationships with responsiveness to epidural stimulation in SCI in retrospective studies, the proposed study is a traditional feasibility study - a prospective investigation to be used to capture preliminary safety and effectiveness information to determine if MRI can/should be used in planning a future pivotal study.
    Detailed Description
    This is an investigator-initiated proof of concept study performed at the University of Colorado Anschutz Medical Campus (CU Anschutz). This 2-case proof-of-concept study will include 2 research participants with motor-complete SCI to evaluate the performance of the Medtronic epidural stimulator for restoring voluntary movement below the level of injury. Participants will be enrolled at CU Anschutz. Screening data will be reviewed to determine participant eligibility. Two participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. The following treatment regimen will be used: epidural stimulation + 6 months of intensive outpatient physical therapy. Total duration of study participation will be 8 months.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Epidural stimulation with PT
    Arm Type
    Experimental
    Arm Description
    Stimulation parameters will be optimized for each lower extremity and joint movement. During physical therapy sessions, electrode configurations may be adjusted as needed to optimize stimulation frequencies, and voltage intensity ranges to best enable voluntary control of lower extremity (ankle, knee, and hip) flexion and extension, as well as standing. Intensive physical therapy will consist of 3 visits per week over the course of 6 months directed by a licensed physical therapist with over a decade of experience working with individuals with SCI, and the epidural stimulator will be ON continuously during these sessions. Physical therapy will involve neurorehabilitation to facilitate voluntary lower extremity movement in the presence of stimulation, with the research participants in the supine, seated, and standing positions.
    Intervention Type
    Device
    Intervention Name(s)
    implanted epidural stimulator
    Intervention Description
    implantable multi-programmable neurostimulation system to deliver electrical stimulation to neural targets in the spinal cord
    Primary Outcome Measure Information:
    Title
    International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS)
    Description
    International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS) will be used to measure the degree of voluntary motor change. LEMS is conducted with the participant lying supine and five key muscle groups on each side are tested for their ability to contract against gravity and resistance. A zero to five scale is used with a maximum possible score of 25. ISNCSCI motor testing has been shown to have adequate to excellent interrater reliability in individuals with SCI, and is a valid tool for this population
    Time Frame
    at day 1, at month 7, and at month 8
    Secondary Outcome Measure Information:
    Title
    The abbreviated World Health Organization Quality of Life (WHOQOL-BREF)
    Description
    The abbreviated World Health Organization Quality of Life (WHOQOL-BREF) instrument will be used to measure the degree of participants' perception of change in quality of life after stimulator implantation. The WHOQOL-BREF assesses quality of life within the context of an individual's culture, value systems, personal goals, standards, and concerns. It has been studied and highly recommended for individuals with SCI.
    Time Frame
    at day 1, at month 7, and at month 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: AIS B SCI diagnosis Beyond 6 months of injury date SCI at a level range of C7-T8 with signs of upper motor neuron injury 18 years or older Height 5'1" to 6'3" Weight 250 lbs or less Sufficient upper extremity strength to manage a stability aide MRI evidence of spared spinal cord neural fibers Exclusion Criteria: Claustrophobia and/or other contraindications to magnetic resonance imaging (MRI) Unstable or symptomatic cardiorespiratory issues, in the opinion of the investigators Recent (within 3 months) history of fracture, contractures, pressure sore, DVT, urinary tract infection, or other infections that might interfere with interventions Contraindications to epidural stimulator implantation surgery Received botox injections into the lower extremities within the past 6 months Pregnancy Cauda Equina injury Any other neurological disorder besides SCI
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrew C Smith, PT, DPT, PhD
    Phone
    303-724-0781
    Email
    andrew.c2.smith@cuanschutz.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew C Smith, PT, DPT, PhD
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34854934
    Citation
    Smith AC, Angeli CA, Ugiliweneza B, Weber KA 2nd, Bert RJ, Negahdar M, Mesbah S, Boakye M, Harkema SJ, Rejc E. Spinal cord imaging markers and recovery of standing with epidural stimulation in individuals with clinically motor complete spinal cord injury. Exp Brain Res. 2022 Jan;240(1):279-288. doi: 10.1007/s00221-021-06272-9. Epub 2021 Dec 2.
    Results Reference
    background
    PubMed Identifier
    33192348
    Citation
    Rejc E, Smith AC, Weber KA 2nd, Ugiliweneza B, Bert RJ, Negahdar M, Boakye M, Harkema SJ, Angeli CA. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 21;14:559313. doi: 10.3389/fnsys.2020.559313. eCollection 2020.
    Results Reference
    background
    PubMed Identifier
    21601270
    Citation
    Harkema S, Gerasimenko Y, Hodes J, Burdick J, Angeli C, Chen Y, Ferreira C, Willhite A, Rejc E, Grossman RG, Edgerton VR. Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study. Lancet. 2011 Jun 4;377(9781):1938-47. doi: 10.1016/S0140-6736(11)60547-3. Epub 2011 May 19.
    Results Reference
    background
    PubMed Identifier
    24713270
    Citation
    Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ. Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans. Brain. 2014 May;137(Pt 5):1394-409. doi: 10.1093/brain/awu038. Epub 2014 Apr 8. Erratum In: Brain. 2015 Feb;138(Pt 2):e330.
    Results Reference
    background
    PubMed Identifier
    30247091
    Citation
    Angeli CA, Boakye M, Morton RA, Vogt J, Benton K, Chen Y, Ferreira CK, Harkema SJ. Recovery of Over-Ground Walking after Chronic Motor Complete Spinal Cord Injury. N Engl J Med. 2018 Sep 27;379(13):1244-1250. doi: 10.1056/NEJMoa1803588. Epub 2018 Sep 24.
    Results Reference
    background

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    Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury

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