NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

Study Identifier:
Neurosleeve 20D.372
ClinicalTrials.gov Identifier:
NCT04798378
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Thomas Jefferson University
Active, not recruiting

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
    Date
    Apr 2020 - Dec 2025
    Patient Requirements
    Sex: Female & Male
    Age: 4+ years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • • Must be 4 years or older
    • Must have weakness in one or both arms such that flexion or extension of the wrist, elbow or shoulder are 3/5 or less on the Manual Muscle Testing Scale
    • The etiology of weakness is due to a neurological disease or injury or orthopedic condition that occurred 6 or more months ago
    • Participant is willing to comply with trial instructions
    • Adult participant is able to provide informed consent prior to enrollment in the study, and for children, child is able to provide assent and designated caregiver (parent or guardian) is able to provide informed consent
    • The participant is fluent in English and, if the participant were a child, at least one parent/guardian were fluent in English
    • Medically stable and living at home in the community.
    • No joint contracture, spasticity or other limitations to range of motion in the affected lower limb(s) precluding the operation of a wearable, powered orthotic device on the arm
    • Sufficient sitting balance to sit in a chair
    • No condition (e.g., severe arthritis, central pain) that would interfere with movement of the legs, ability to understand verbal commands and cooperate with test procedures.
    • No condition that would pose a risk to the application of electrical current to the body (e.g., skin conditions or skin breakdown)
    Exclusion Criteria
    • • Visual impairment such that following visually-guided instructions would be challenging even with ordinary corrective lenses
    • Orthopedic conditions of either arm that would affect performance on study
    • Untreated psychiatric or neurologic disturbances that would affect motivation and trial participation
    • Excessive pain in one or both of the arms (\> 5 on a 10-point visual analog scale)
    • Excessive spasticity at one or both arms, as defined as a score of \> 2 on the Modified Ashworth Spasticity Scale
    • Advice from any of the participant's health providers that upper extremity powered orthotics or electrical stimulation were contra-indicated
    • Presence of an implanted medical device in the body (such as cardiac pacemaker, implanted defibrillator, metallic device)
    • Metal implants or exposed metal in the weak or paralyzed arm
    • Lack of access to internet or wireless coverage to enable telemedicine-guided sessions
    • Any history of seizure or epilepsy (only an exclusion criterion for those seeking to undergo optional transcranial magnetic stimulation)
    • Currently taking the medication bupropion (only an exclusion criterion for those seeking to undergo optional transcranial magnetic stimulation)
    • Any history of prior neurosurgical procedure (only an exclusion criterion for those seeking to undergo optional transcranial magnetic stimulation)
    • Known or suspected skull defect (only an exclusion criterion for those seeking to undergo optional transcranial magnetic stimulation)
    • Any history of alcohol or other substance use
    • Other conditions or circumstances that, in the opinion of the investigators, would preclude safe and/or effective participation, including severe skin conditions, and/or other sequelae that may be contraindicated for using a powered orthotic or using electrical stimulation, as well as personal circumstances

    Protocol Summary

    The purpose of this study is to investigate if a person with weakness or paralysis in one or both arms, can use the NuroSleeve combined powered arm brace (orthosis) and muscle stimulation system to help restore movement in one arm sufficient to perform daily activities. This study could lead to the development of a product that could allow people with arm weakness or arm paralysis to use the NuroSleeve and similar devices to improve arm health and independent function.

    Trial Locations

    Location
    Status
    Location
    Nemours Children's Hospital
    Wilmington, Delaware, United States, 19803
    Status
    N/A
    Location
    Thomas Jefferson University
    Philadelphia, Pennsylvania, United States, 19107
    Status
    N/A

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