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Upper Extremity Training for Chronic Cervical Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
upper extremity stimulation
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age.
  • spinal cord injury for greater than or equal to 6 months.
  • spinal cord injury at a cervical neurologic level of injury.

Exclusion Criteria:

  • ventilator dependent.
  • history of fractures.
  • pressure sore or skin issues.
  • history of illicit drug abuse.
  • history of cardiac, respiratory, bladder, renal or other medical disorder unrelated to spinal cord injury.
  • bladder Botox injections less than 12 months prior.
  • muscle Botox injections less than 12 months prior.
  • colostomy bag or urostomy.
  • implanted pump (i.e., baclofen pump, pain pump, etc).
  • If I am female: I am pregnant at the time of enrollment or planning to become pregnant during the course of the study.
  • unable to wean from anti-spasticity medication.
  • contraindications to MRI imaging (pacemaker, metallic foreign body, aneurysm clip, etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    transcutaneous stimulation

    Arm Description

    transcutaneous stimulation 60 sessions Transcutaneous stimulation 40sessions Transcutaneous stimulation 20 sessions

    Outcomes

    Primary Outcome Measures

    Neuro Recovery Scale ( NRS).
    Measure of the degree a person who has sustained a spinal cord injury (SCI) has recovered the ability to perform functional tasks relative to how the individual performed these tasks prior to injury. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This type of scale can be administered verbally.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 12, 2021
    Last Updated
    June 10, 2021
    Sponsor
    Kessler Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04921592
    Brief Title
    Upper Extremity Training for Chronic Cervical Spinal Cord Injury
    Official Title
    Neuromodulation Training for Upper Extremity Recovery for Chronic Cervical Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 14, 2021 (Anticipated)
    Primary Completion Date
    June 15, 2022 (Anticipated)
    Study Completion Date
    November 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kessler Foundation

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core.
    Detailed Description
    This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core. Activity-based recovery training aims to advance independence without the use of assistive devices. Spinal cord transcutaneous stimulation is an electrical stimulation that is provided on top of the skin over specific areas of the spinal cord to activate the circuitry for the activity that is being trained and reconnect with pathways between the brain and spinal cord. i) Physical evaluation by the clinician or physician including the Classification of Spinal Cord Injury (ISNCSCI exam. ii) A series of tests to evaluate the trunk, arm function with and without using tests to evaluate muscle activation. iii) A series of questionnaires to evaluate function and quality of life iv) Two separate Magnetic Resonance Imaging (MRI) of spinal column (head to hip). Randomized to one of three groups: Group 1: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 60 training sessions transcutaneous spinal stimulation. Group 2: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 40 training sessions of transcutaneous spinal stimulation. The group will then complete 20 sessions of rehabilitation therapy of the upper extremities and trunk (no stimulation). Group 3: will be will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 20 training sessions of transcutaneous spinal stimulation. The group will then complete 40 sessions of rehabilitation therapy of the upper extremities and trunk (no stimulation). Transcutaneous spinal stimulation will involve stimulating the spinal segments between C5/6 to lumber regions. Training time will be approximately 1 hour, 3-4 times per week. Rehabilitation therapy will involve exercises concentrating on fingers, hand, arm and trunk function. A physical therapist will be at training and testing sessions.

    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
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Randomized into 1 of 3 groups
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    transcutaneous stimulation
    Arm Type
    Experimental
    Arm Description
    transcutaneous stimulation 60 sessions Transcutaneous stimulation 40sessions Transcutaneous stimulation 20 sessions
    Intervention Type
    Other
    Intervention Name(s)
    upper extremity stimulation
    Other Intervention Name(s)
    Activity-Based Recovery Therapy (ABRT)
    Intervention Description
    transcutaneous stimulation of the upper extremities
    Primary Outcome Measure Information:
    Title
    Neuro Recovery Scale ( NRS).
    Description
    Measure of the degree a person who has sustained a spinal cord injury (SCI) has recovered the ability to perform functional tasks relative to how the individual performed these tasks prior to injury. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This type of scale can be administered verbally.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age. spinal cord injury for greater than or equal to 6 months. spinal cord injury at a cervical neurologic level of injury. Exclusion Criteria: ventilator dependent. history of fractures. pressure sore or skin issues. history of illicit drug abuse. history of cardiac, respiratory, bladder, renal or other medical disorder unrelated to spinal cord injury. bladder Botox injections less than 12 months prior. muscle Botox injections less than 12 months prior. colostomy bag or urostomy. implanted pump (i.e., baclofen pump, pain pump, etc). If I am female: I am pregnant at the time of enrollment or planning to become pregnant during the course of the study. unable to wean from anti-spasticity medication. contraindications to MRI imaging (pacemaker, metallic foreign body, aneurysm clip, etc.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    LeighAnn Martinez, BA
    Phone
    973.324.3557
    Email
    lmartinez@kesslerfoundation.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gail F Forrest, PhD
    Organizational Affiliation
    Kessler Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Upper Extremity Training for Chronic Cervical Spinal Cord Injury

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