Clinical trial NCT05965713: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Hemiparesis
Spasticity as Sequela of Stroke
Brain Computer Interface
Keywords: Neurolutions
IpsiHand
Lead sponsor: Neurolutions, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Washington University School of Medicine
First posted: 2023-07-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Upper Extremity Remote Fugl-Meyer
timeFrame: Baseline assessment
measure: Upper Extremity Remote Fugl-Meyer
timeFrame: 2 week assessment
measure: Upper Extremity Remote Fugl-Meyer
timeFrame: 4 week assessment
measure: Upper Extremity Remote Fugl-Meyer
timeFrame: 6 week assessment
measure: Upper Extremity Remote Fugl-Meyer
timeFrame: 8 week assessment
measure: Upper Extremity Remote Fugl-Meyer
timeFrame: 10 week assessment
measure: Upper Extremity Remote Fugl-Meyer
timeFrame: 12 week assessment (outcome assessment)
Secondary outcomes:
measure: Motor Activity Log
timeFrame: Baseline assessment
measure: Motor Activity Log
timeFrame: 12 week completion
measure: Gross Grasp Strength
timeFrame: Baseline assessment
measure: Gross Grasp Strength
timeFrame: 12 week completion
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Neurolutions
state: Missouri
Study officials:
References: