National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

July 25, 2023 updated by: Neurolutions, Inc.

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Neurolutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline assessment
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.
2 week assessment
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 week assessment
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.
6 week assessment
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.
8 week assessment
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.
10 week assessment
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.
12 week assessment (outcome assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline assessment
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
12 week completion
Gross Grasp Strength
Time Frame: Baseline assessment
Evaluation of gross grasp strength via dynamometry; lowest score=0 lbs, maximal score 150lbs
Baseline assessment
Gross Grasp Strength
Time Frame: 12 week completion
Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs
12 week completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurolutions, Inc.

Collaborators

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

January 10, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • National Remote IpsiHand Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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