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IpsiHand System for Rehabilitation of the Arm and Hand After Stroke

Primary Purpose

Stroke, Hemiparesis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IpsiHand Treatment
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hemiparesis, Rehabilitation, Upper Extremity, Neurological Rehabilitation, Neuronal Plasticity, Brain-Computer Interfaces, Robotics

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of stroke(s), with most recent stroke at least 6 months prior to study start (can be ischemic or hemorrhagic)
  • PROM: Full extension of digits 2 and 3 at MPs, PIPs, and DIPs
  • English speaking
  • Intact cognition to provide informed consent
  • Intact language skills to comprehend and follow directions
  • Experiencing difficulty performing ADLs with affected upper limb

  • Upper extremity Botox allowable, but not required

    • Botox users must continue regimen at regular intervals for duration of study
    • Botox users will provide clinic note for each injection (date, dose, and muscle location)
    • Botox + Study Schedule
  • At study initiation, Botox injection will occur between 3-7 days prior to baseline measurement and initiation of device use
  • Repeat Botox injections must be completed at least 3 days prior to any administration of the outcome measures

Exclusion Criteria:

  • Concurrent participation in another study
  • Co-morbid orthopedic condition/pain limiting functional use of the impaired upper limb
  • History of neurological disorder other than stroke
  • Botox user unable to comply with above noted requirements
  • Ongoing physical or occupational therapy addressing the upper limb
  • Ongoing electric stimulation or other rehabilitative devices (e.g. robotics, virtual reality) to upper limb
  • Cognitive impairment: Short Blessed Test Score 9
  • Significant spasticity: Modified Ashworth Scale score 3 at the elbow
  • Significant hemispatial neglect: Mesulam Cancellation Test 3 unilaterally
  • Insufficient Strength: Motricity Index score for shoulder abduction 18
  • Significantly impaired sensation of impaired upper limb: National Institutes of Health Stroke Scale - Item 8 (Sensory) score of 2
  • History of cranioplasty
  • History of seizure disorder
  • No changes to usual exercises, splint use, or oral baclofen/anti-spasticity medication use during trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    IpsiHand Treatment

    Arm Description

    All participants will receive treatment with IpsiHand device

    Outcomes

    Primary Outcome Measures

    Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity
    The Fugl-Meyer is a scale that measures capacity of the arm. There are 33 items that evaluate reflexes, active movement, grasp patterns, speed, and coordination of the arm and hand. Each item is scored from 0-2, with a maximum total score of 66. Higher scores indicate better performance.

    Secondary Outcome Measures

    Action Research Arm Test
    The ARAT is a scale that measures activity participation of the arm. There are 19 items that several types of grasps, grips, pinches, and gross movements of the arm and hand. Each item is scored from 0-3, with a maximum total score of 57. Higher scores indicate better performance.
    Box and Block Test
    The Box and Block Test measures the number of blocks a participant can pick up and place over a patrician in 1 minute. The number of blocks successfully moved are counted and a higher number indicates better performance.

    Full Information

    First Posted
    October 10, 2019
    Last Updated
    August 4, 2020
    Sponsor
    Columbia University
    Collaborators
    Neurolutions, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04123808
    Brief Title
    IpsiHand System for Rehabilitation of the Arm and Hand After Stroke
    Official Title
    Dosing Effects of an Upper Extremity Rehabilitation Program Using a Brain-Computer Interface Mediated Robotic Hand Orthosis for Chronic Stroke Patients: IpsiHand System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Closed by sponsor
    Study Start Date
    December 2, 2019 (Actual)
    Primary Completion Date
    June 30, 2020 (Actual)
    Study Completion Date
    June 30, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Columbia University
    Collaborators
    Neurolutions, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to assess whether the NeuroLutions Upper Extremity Rehabilitation System (known as IpsiHand) will help stroke patients regain strength and functional movements in their arm. The IpsiHand system involves using a hand robotic device that is controlled by brain waves, known as a Brain-Computer Interface (BCI). By using the device, participants will be harnessing brainwaves from the side of their brain not affected by stroke to control the robotic device on the hand that is weaker from the stroke.
    Detailed Description
    This trial aims to assess the effectiveness of the NeuroLutions Upper Extremity Rehabilitation System, known as IpsiHand, on functional motor recovery and neuroplasticity for chronic stroke survivors with hemiparesis (N=27). The IpsiHand system involves a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis. Participants will complete 16-32 weeks of home therapy with the IpsiHand system.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Hemiparesis
    Keywords
    Stroke, Hemiparesis, Rehabilitation, Upper Extremity, Neurological Rehabilitation, Neuronal Plasticity, Brain-Computer Interfaces, Robotics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    An occupational therapist independent to the study will review and score 2 outcome measures (Fugl-Meyer and Action Research Arm Test). The study coordinator will randomize the order of the videos for each participant, so that the outcome assessor will not know which time point they are scoring. In other words, the video-outcome assessor will be blinded to the order of the assessments as they are scoring them but will not be blinded to the intervention as all participants will be receiving the same intervention.
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IpsiHand Treatment
    Arm Type
    Experimental
    Arm Description
    All participants will receive treatment with IpsiHand device
    Intervention Type
    Device
    Intervention Name(s)
    IpsiHand Treatment
    Intervention Description
    The IpsiHand system utilizes a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis donned on the affected upper extremity as participants are guided through a rehabilitation program on a tablet. Participants will complete 16-32 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 3 months post no-device use, to track progress.
    Primary Outcome Measure Information:
    Title
    Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity
    Description
    The Fugl-Meyer is a scale that measures capacity of the arm. There are 33 items that evaluate reflexes, active movement, grasp patterns, speed, and coordination of the arm and hand. Each item is scored from 0-2, with a maximum total score of 66. Higher scores indicate better performance.
    Time Frame
    Baseline through 3 months post no device use
    Secondary Outcome Measure Information:
    Title
    Action Research Arm Test
    Description
    The ARAT is a scale that measures activity participation of the arm. There are 19 items that several types of grasps, grips, pinches, and gross movements of the arm and hand. Each item is scored from 0-3, with a maximum total score of 57. Higher scores indicate better performance.
    Time Frame
    Baseline through 3 months post no device use
    Title
    Box and Block Test
    Description
    The Box and Block Test measures the number of blocks a participant can pick up and place over a patrician in 1 minute. The number of blocks successfully moved are counted and a higher number indicates better performance.
    Time Frame
    Baseline through 3 months post no device use

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of stroke(s), with most recent stroke at least 6 months prior to study start (can be ischemic or hemorrhagic) PROM: Full extension of digits 2 and 3 at MPs, PIPs, and DIPs English speaking Intact cognition to provide informed consent Intact language skills to comprehend and follow directions Experiencing difficulty performing ADLs with affected upper limb Upper extremity Botox allowable, but not required Botox users must continue regimen at regular intervals for duration of study Botox users will provide clinic note for each injection (date, dose, and muscle location) Botox + Study Schedule At study initiation, Botox injection will occur between 3-7 days prior to baseline measurement and initiation of device use Repeat Botox injections must be completed at least 3 days prior to any administration of the outcome measures Exclusion Criteria: Concurrent participation in another study Co-morbid orthopedic condition/pain limiting functional use of the impaired upper limb History of neurological disorder other than stroke Botox user unable to comply with above noted requirements Ongoing physical or occupational therapy addressing the upper limb Ongoing electric stimulation or other rehabilitative devices (e.g. robotics, virtual reality) to upper limb Cognitive impairment: Short Blessed Test Score 9 Significant spasticity: Modified Ashworth Scale score 3 at the elbow Significant hemispatial neglect: Mesulam Cancellation Test 3 unilaterally Insufficient Strength: Motricity Index score for shoulder abduction 18 Significantly impaired sensation of impaired upper limb: National Institutes of Health Stroke Scale - Item 8 (Sensory) score of 2 History of cranioplasty History of seizure disorder No changes to usual exercises, splint use, or oral baclofen/anti-spasticity medication use during trial
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joel Stein, MD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28550098
    Citation
    Bundy DT, Souders L, Baranyai K, Leonard L, Schalk G, Coker R, Moran DW, Huskey T, Leuthardt EC. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke. 2017 Jul;48(7):1908-1915. doi: 10.1161/STROKEAHA.116.016304. Epub 2017 May 26.
    Results Reference
    background
    PubMed Identifier
    29761128
    Citation
    Cervera MA, Soekadar SR, Ushiba J, Millan JDR, Liu M, Birbaumer N, Garipelli G. Brain-computer interfaces for post-stroke motor rehabilitation: a meta-analysis. Ann Clin Transl Neurol. 2018 Mar 25;5(5):651-663. doi: 10.1002/acn3.544. eCollection 2018 May.
    Results Reference
    background
    PubMed Identifier
    24136129
    Citation
    Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.
    Results Reference
    background

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    IpsiHand System for Rehabilitation of the Arm and Hand After Stroke

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