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National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

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: NCT05965713
Recruitment Status : Not yet recruiting
First Posted : July 28, 2023
Last Update Posted : July 28, 2023
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Neurolutions, Inc.

Study Description
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Brief Summary:
The goal of this study is to define the efficacy of fully remote home-based BCI therapy in chronic hemiparetic subcortical stroke patients. A randomized controlled study using the integrated remote BCI system will be tested against standard exercise therapy to determine the efficacy of motor improvement in chronic stroke patients with an upper extremity hemiparesis. Specifically, the integrated BCI system will include 1) the remote screening and motor assessment system for the upper extremity and 2) the BCI-controlled robotic hand exoskeleton (i.e. IpsiHand).

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Spasticity as Sequela of Stroke Brain Computer Interface Device: Neurolutions IpsiHand System Other: Standard of Care - Home Exercise Program for Upper Extremity Not Applicable

Detailed Description:
The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor impaired stroke survivors. This ultimate goal is to develop a system that allows for enhanced functional capability and works consistently over a long-term basis and is accessible remotely no matter location or access to healthcare. In developing a new rehabilitation method, the researchers hope to create a system that allows for closed loop feedback through a robotic hand orthosis on the motor impaired side of stroke patients in response to intended movements of the muscles. The method, if successful, would represent an ideal, non-invasive method of promoting motor learning and recovery in stroke survivors. The ability to operate robotic hand orthosis using electrical signals of the brain is rapidly leaving the realm of science fiction and becoming a realistic goal of the clinical community. The current advances in BCI controlled neuroprosthetics could have immeasurable influence on adult patients with severe motor impairments from stroke. Even further on the horizon the insights developed from such work could substantively alter the way all stroke patients are treated and rehabilitated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study staff will screen participants virtually or in person for eligibility after completing the informed consent process and documentation. After screening for study eligibility has occurred, the initial EEG screening will take place for all individuals who meet the criteria for the study as to ensure no preference to subjects with optimal signals for use of the IpsiHand. Once EEG screenings have been completed, the participant will be randomly assigned to Group 1 (BCI treatment) or Group 2 (standard of care treatment group). Each group will complete a daily therapy regimen. In Group 1 (BCI group)- will complete daily BCI therapy. In Group 2 (standard of care)- individuals will complete standard of care therapy program daily for 12 weeks provided by an occupational therapist.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : January 10, 2025
Estimated Study Completion Date : March 31, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: BCI treatment Group using the IpsiHand

Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Subjects will undergo an EEG screening protocol to ensure that a consistent control signal will be present to control the IpsiHand device. After an EEG screening session is complete, the participants screening data will be analyzed to ensure that sufficient cortical signals are present. Randomization for assignment to group 1 or 2 will then occur. Once assigned to group 1, if consistent signals are found, the participant will then continue to Phase 2.

Phase 2: Group 1 subjects will be provided with a Neurolutions IpsiHand BCI system, which combines a novel powered exoskeleton with a commercial EEG amplifier and active electrode system. The exoskeleton opens and closes the patient's hand in a three-finger pinch grip. Patients will use the BCI system on a minimum of 5 days per week for 12 weeks. Patients will complete five or more 10-minute runs of the BCI task per day.

 Device: Neurolutions IpsiHand System
The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 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 12 weeks completion of IpsiHand use.
Experimental: Standard of Care - Home Exercise Program for Upper Extremity

Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Once randomized, the participant will be assigned to group 2 to begin standard of care treatment at home.

Phase 2: After being assigned to Group 2, subjects will serve as the control group in the study. Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks to control for the non-specific motor and sensory effects of BCI training. To help ensure compliance with the at-home portion of the protocol in the control group, participants will receive daily virtual monitoring from the study clinical specialist.

 Other: Standard of Care - Home Exercise Program for Upper Extremity
Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Upper Extremity Remote Fugl-Meyer [ Time Frame: Baseline assessment ]
    Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.

  2. Upper Extremity Remote Fugl-Meyer [ Time Frame: 2 week assessment ]
    Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.

  3. Upper Extremity Remote Fugl-Meyer [ Time Frame: 4 week assessment ]
    Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.

  4. Upper Extremity Remote Fugl-Meyer [ Time Frame: 6 week assessment ]
    Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.

  5. Upper Extremity Remote Fugl-Meyer [ Time Frame: 8 week assessment ]
    Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.

  6. Upper Extremity Remote Fugl-Meyer [ Time Frame: 10 week assessment ]
    Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.

  7. Upper Extremity Remote Fugl-Meyer [ Time Frame: 12 week assessment (outcome assessment) ]
    Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.


Secondary Outcome Measures :
  1. Motor Activity Log [ Time Frame: Baseline assessment ]
    Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score= 140

  2. Motor Activity Log [ Time Frame: 12 week completion ]
    Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score=140

  3. Gross Grasp Strength [ Time Frame: Baseline assessment ]
    Evaluation of gross grasp strength via dynamometry; lowest score=0 lbs, maximal score 150lbs

  4. Gross Grasp Strength [ Time Frame: 12 week completion ]
    Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults age (18-85)
  2. Adults who sustained a CVA
  3. Have upper extremity hemiparesis/hemiplegia
  4. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.

Exclusion Criteria:

  1. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
  2. Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded.
  3. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit.
  4. Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded.
  5. Participants receiving any formal upper extremity therapy will be excluded.
  6. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded.
  7. Participants who are pregnant or breast-feeding will be excluded.
  8. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05965713


Contacts
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Contact: Kelly Carr, MOT, OTR/L 314-272-2575 kcarr@neurolutions.com
Contact: Lauren Souders, MOT, OTR/L 314-272-2575 lauren@neurolutions.com

Locations
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United States, Missouri
Neurolutions
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Neurolutions, Inc.
Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Neurolutions, Inc.
ClinicalTrials.gov Identifier: NCT05965713    
Other Study ID Numbers: National Remote IpsiHand Study
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: July 28, 2023
Last Verified: July 2023
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.: No
Keywords provided by Neurolutions, Inc.:
Neurolutions
IpsiHand
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations