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National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

Primary Purpose

Stroke, Hemiparesis, Spasticity as Sequela of Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurolutions IpsiHand System
Standard of Care - Home Exercise Program for Upper Extremity
Sponsored by
Neurolutions, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Neurolutions, IpsiHand

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults age (18-85) Adults who sustained a CVA Have upper extremity hemiparesis/hemiplegia 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: 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. 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. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit. 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. Participants receiving any formal upper extremity therapy will be excluded. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded. Participants who are pregnant or breast-feeding will be excluded. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.

Sites / Locations

  • Neurolutions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BCI treatment Group using the IpsiHand

Standard of Care - Home Exercise Program for Upper Extremity

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Motor Activity Log
Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score= 140
Motor Activity Log
Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score=140
Gross Grasp Strength
Evaluation of gross grasp strength via dynamometry; lowest score=0 lbs, maximal score 150lbs
Gross Grasp Strength
Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs

Full Information

First Posted
July 18, 2023
Last Updated
July 25, 2023
Sponsor
Neurolutions, Inc.
Collaborators
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05965713
Brief Title
National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
January 10, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurolutions, Inc.
Collaborators
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis, Spasticity as Sequela of Stroke, Brain Computer Interface
Keywords
Neurolutions, IpsiHand

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCI treatment Group using the IpsiHand
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care - Home Exercise Program for Upper Extremity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neurolutions IpsiHand System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care - Home Exercise Program for Upper Extremity
Intervention Description
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
Primary Outcome Measure Information:
Title
Upper Extremity Remote Fugl-Meyer
Description
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time Frame
Baseline assessment
Title
Upper Extremity Remote Fugl-Meyer
Description
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time Frame
2 week assessment
Title
Upper Extremity Remote Fugl-Meyer
Description
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time Frame
4 week assessment
Title
Upper Extremity Remote Fugl-Meyer
Description
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time Frame
6 week assessment
Title
Upper Extremity Remote Fugl-Meyer
Description
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time Frame
8 week assessment
Title
Upper Extremity Remote Fugl-Meyer
Description
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time Frame
10 week assessment
Title
Upper Extremity Remote Fugl-Meyer
Description
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time Frame
12 week assessment (outcome assessment)
Secondary Outcome Measure Information:
Title
Motor Activity Log
Description
Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score= 140
Time Frame
Baseline assessment
Title
Motor Activity Log
Description
Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score=140
Time Frame
12 week completion
Title
Gross Grasp Strength
Description
Evaluation of gross grasp strength via dynamometry; lowest score=0 lbs, maximal score 150lbs
Time Frame
Baseline assessment
Title
Gross Grasp Strength
Description
Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs
Time Frame
12 week completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults age (18-85) Adults who sustained a CVA Have upper extremity hemiparesis/hemiplegia 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: 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. 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. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit. 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. Participants receiving any formal upper extremity therapy will be excluded. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded. Participants who are pregnant or breast-feeding will be excluded. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Carr, MOT, OTR/L
Phone
314-272-2575
Email
kcarr@neurolutions.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Souders, MOT, OTR/L
Phone
314-272-2575
Email
lauren@neurolutions.com
Facility Information:
Facility Name
Neurolutions
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://academic.oup.com/braincomms/article/4/3/fcac136/6591904?guestAccessKey=e52570be-8afa-4b87-9136-570b2adcfb60&login=false
Description
Theta-gamma coupling as a cortical biomarker of brain-computer interface-mediated motor recovery in chronic stroke
URL
https://pubmed.ncbi.nlm.nih.gov/15839599/
Description
A variables associated with occupational and physical therapy stroke rehabilitation utilization and outcomes
URL
https://pubmed.ncbi.nlm.nih.gov/28835194/
Description
Inequities in access to inpatient rehabilitation after stroke: an international scoping review
URL
https://pubmed.ncbi.nlm.nih.gov/15843670/
Description
Clinical practice. Rehabilitation after stroke
URL
http://koreascience.or.kr/article/JAKO201319133640292.page
Description
Brain-Computer Interface in Stroke Rehabilitation
URL
https://pubmed.ncbi.nlm.nih.gov/18258825/
Description
Think to move: a neuromagnetic brain-computer interface (BCI) system for chronic stroke
URL
https://pubmed.ncbi.nlm.nih.gov/20208465/
Description
Feasibility of a new application of noninvasive Brain Computer Interface (BCI): a case study of training for recovery of volitional motor control after stroke
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4114185/
Description
Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke
URL
https://pubmed.ncbi.nlm.nih.gov/16235812/
Description
An evaluation framework for a rural home-based telerehabilitation network
URL
https://pubmed.ncbi.nlm.nih.gov/19169175/
Description
Disparities in postacute stroke rehabilitation disposition to acute inpatient rehabilitation vs. home: findings from the North Carolina Hospital Discharge Database
URL
https://pubmed.ncbi.nlm.nih.gov/10916961/
Description
Barriers to care among racial/ethnic groups under managed care
URL
https://pubmed.ncbi.nlm.nih.gov/20542850/
Description
Stroke patients' and carers' perception of barriers to accessing stroke information
URL
https://pubmed.ncbi.nlm.nih.gov/23738231/
Description
Rehabilitation with poststroke motor recovery: a review with a focus on neural plasticity
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4083225/
Description
Brain-computer interface with somatosensory feedback improves functional recovery from severe hemiplegia due to chronic stroke
URL
https://pubmed.ncbi.nlm.nih.gov/24590225/
Description
Efficacy of brain-computer interface-driven neuromuscular electrical stimulation for chronic paresis after stroke

Learn more about this trial

National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

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