SBIR-STTR Award

A Fully Remote Telehealth Brain Computer Interface and Assessment System for Motor Rehabilitation of Chronic Stroke
Award last edited on: 11/17/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$1,958,129
Award Phase
2
Solicitation Topic Code
865
Principal Investigator
Kern Bhugra

Company Information

Neurolutions Inc

1101 Pacific Avenue Suite 300
Santa Cruz, CA 95060
   (408) 398-7214
   N/A
   www.neurolutions.com
Location: Single
Congr. District: 19
County: Santa Cruz

Phase I

Contract Number: 1R44HD105579-01
Start Date: 9/23/2021    Completed: 4/30/2022
Phase I year
2021
Phase I Amount
$299,891
A substantial unmet clinical need and large commercial opportunity centers on chronic stroke patients' poor access to advanced rehabilitation care [1, 2]. In rehabilitating chronically motor-impaired stroke survivors with a brain computer interface (BCI), the current barrier for further advancement of telehealth BCI-driven neurorehabilitation is that there is no integrated software and hardware system that is easily deployable toscreen, treat, and track chronic stroke patients in their home environments. Our company Neurolutions' long-term goal of this research is to create a widely scalable BCI rehabilitation solution that can restore function topatients with a chronic stroke-induced motor deficit. Thus, creating and vetting a technical infrastructure to enableremote acquisition/analysis of a patient's brain signals and their motor function is essential to achieving this goal.The objective of this proposal is to create a mail-delivered, internet-connected system that enables home-basedEEG screening for BCI-rehab candidacy and remote motor assessment of upper extremity response to BCI-rehab treatment. Our central hypothesis is that fully remote assessment, enrollment, and treatment of chronicstroke patients with an upper extremity motor deficit with the use of a BCI-controlled robotic hand exoskeletonwill demonstrate significant improvement in hand function. Thus, the rationale is that enabling patients to beeffectively screened, treated and monitored at home removes the need for patients to travel to health careenvironments and thus enables a much larger population to access this technology. With extensive experiencein stroke-BCI and home-based care [3], we are well prepared to pursue the objective of this proposal with thefollowing Specific Aims: 1) Create a home-based EEG screening system for chronic stroke patients to determinecandidacy for BCI rehabilitation of upper extremity motor deficit, 2) Create a home-based system for performingphysical motor assessments that are equivalent to standard in-person Fugl-Meyer (FM) assessment of upperextremity function, 3) Define the accuracy of home-based Fugl-Meyer (FM) assessment against gold standardin-person FM assessment, and 4) Define the efficacy of fully remote home-based BCI therapy in chronichemiparetic subcortical stroke patients. This project is innovative because 1) it represents a departure from thestatus quo by expanding the role the unaffected hemisphere can play in BCI-mediated stroke rehabilitation and2) the focus on full course of treatment (screening, treatment and monitoring) occurring in the home significantlydeparts from the commercial models of how advanced BCI-mediated rehabilitation is delivered. This project willleverage the core Neurolutions BCI rehabilitation technology, the IpsiHand, which was recently given aBreakthrough Device designation by the FDA. The proposed research will be significant because the creation ofan integrated system that can assess and treat chronic stroke patients remotely will radically increase accessand therapeutic benefit to a much larger percent of this underserved population. Collectively, the successfulexecution of this project will reduce the personal and social burden of stroke for millions of Americans.

Public Health Relevance Statement:
Project Narrative The proposed research is relevant to public health because developing a technology solution that enhances access to neuroprosthetic rehabilitation of chronic stroke will fundamentally expand the number of patients that can be treated with these advanced approaches to induce a functional recovery. Thus, the proposed research is relevant to the NINDS mission, which is to reduce the burden of the neurologic disease of stroke.

Project Terms:
Academic Medical Centers ; University Medical Centers ; Affect ; Brain ; Brain Nervous System ; Encephalon ; Electroencephalography ; EEG ; Environment ; Goals ; Gold ; Hand ; Health Services Accessibility ; Access to Care ; access to health services ; access to services ; access to treatment ; accessibility to health services ; availability of services ; care access ; health service access ; health services availability ; service availability ; treatment access ; hemiparesis ; hemiparetic ; Mission ; Persons ; nervous system disorder ; Nervous System Diseases ; Neurologic Disorders ; Neurological Disorders ; neurological disease ; Occupational Therapist ; Orthotic Devices ; Orthosis ; orthotics ; Patients ; Play ; Public Health ; Quality of life ; QOL ; Rehabilitation therapy ; Medical Rehabilitation ; Rehabilitation ; rehab therapy ; rehabilitative ; rehabilitative therapy ; Research ; Robotics ; Role ; social role ; Safety ; Signal Transduction ; Cell Communication and Signaling ; Cell Signaling ; Intracellular Communication and Signaling ; Signal Transduction Systems ; Signaling ; biological signal transduction ; Computer software ; Software ; Stroke ; Apoplexy ; Brain Vascular Accident ; Cerebral Stroke ; Cerebrovascular Apoplexy ; Cerebrovascular Stroke ; brain attack ; cerebral vascular accident ; cerebrovascular accident ; Technology ; Testing ; Travel ; Work ; Healthcare ; health care ; Mediating ; Caring ; base ; sensor ; improved ; neurological rehabilitation ; Neuro rehabilitation ; Neurorehabilitation ; neurological rehab ; neurorehab ; stroke rehabilitation ; rehabilitation after stroke ; stroke rehab ; Chronic ; Clinical ; Phase ; Link ; Evaluation ; Recovery ; Internet ; WWW ; web ; world wide web ; Therapeutic ; mechanical ; Mechanics ; Home environment ; System ; American ; experience ; exoskeletal ; exoskeleton ; cohort ; functional recovery ; Recovery of Function ; neuro-prosthetic ; neuroprosthetic ; neuroprosthesis ; Devices ; social ; motor deficit ; intervention therapy ; Therapeutic Intervention ; Modeling ; response ; stroke treatment ; treating stroke ; stroke therapy ; Intervention Strategies ; interventional strategy ; Intervention ; Membrum superius ; Upper Limb ; Upper Extremity ; Institution ; telehealth ; Address ; Base of the Brain ; Motor ; Enrollment ; enroll ; Monitor ; traditional therapy ; National Institute of Neurological Disorders and Stroke ; NINDS ; National Institute of Neurological Diseases and Stroke ; post stroke ; after stroke ; poststroke ; Underserved Population ; under served group ; under served people ; under served population ; underserved group ; underserved people ; Outcome ; brain computer interface ; Population ; innovation ; innovate ; innovative ; chronic stroke ; rehabilitation technology ; rehab technology ; hand rehabilitation ; hand function rehabilitation ; hand function restoration ; hand rehab ; improve hand function ; improvement in hand function ; recover hand function ; recovery of hand function ; restore hand function ; functional improvement ; function improvement ; motor impairment ; movement impairment ; movement limitation ; functional restoration ; restore function ; restore functionality ; restore lost function ; screening ; sensory input ; robot exoskeleton ; robotic exoskeleton ; wearable robotics ; stroke survivor ; rehabilitative care ; rehabilitation care ; motor rehabilitation ; motor rehab ; exercise rehabilitation ; rehabilitative exercise ; robot control ; robotic control ; Exercise Therapy ; stroke patient ; Infrastructure ; randomized controlled study ; COVID-19 pandemic ; COVID crisis ; COVID epidemic ; COVID pandemic ; COVID-19 crisis ; COVID-19 epidemic ; COVID-19 global health crisis ; COVID-19 global pandemic ; COVID-19 health crisis ; COVID-19 public health crisis ; COVID19 crisis ; COVID19 epidemic ; COVID19 global health crisis ; COVID19 global pandemic ; COVID19 health crisis ; COVID19 pandemic ; COVID19 public health crisis ; SARS-CoV-2 epidemic ; SARS-CoV-2 global health crisis ; SARS-CoV-2 global pandemic ; SARS-CoV-2 pandemic ; SARS-CoV2 epidemic ; SARS-CoV2 pandemic ; SARS-coronavirus-2 epidemic ; SARS-coronavirus-2 pandemic ; Severe Acute Respiratory Syndrome CoV 2 epidemic ; Severe Acute Respiratory Syndrome CoV 2 pandemic ; Severe acute respiratory syndrome coronavirus 2 epidemic ; Severe acute respiratory syndrome coronavirus 2 pandemic ; corona virus disease 2019 epidemic ; corona virus disease 2019 pandemic ; coronavirus disease 2019 crisis ; coronavirus disease 2019 epidemic ; coronavirus disease 2019 global health crisis ; coronavirus disease 2019 global pandemic ; coronavirus disease 2019 health crisis ; coronavirus disease 2019 pandemic ; coronavirus disease 2019 public health crisis ; coronavirus disease crisis ; coronavirus disease epidemic ; coronavirus disease pandemic ; severe acute respiratory syndrome coronavirus 2 global health crisis ; severe acute respiratory syndrome coronavirus 2 global pandemic ; remote screening ; Home ;

Phase II

Contract Number: 4R44HD105579-02
Start Date: 9/1/2022    Completed: 8/31/2024
Phase II year
2022
(last award dollars: 2023)
Phase II Amount
$1,658,238

A substantial unmet clinical need and large commercial opportunity centers on chronic stroke patients'poor access to advanced rehabilitation care [1, 2]. In rehabilitating chronically motor-impaired stroke survivorswith a brain computer interface (BCI), the current barrier for further advancement of telehealth BCI-drivenneurorehabilitation is that there is no integrated software and hardware system that is easily deployable toscreen, treat, and track chronic stroke patients in their home environments. Our company Neurolutions' long-term goal of this research is to create a widely scalable BCI rehabilitation solution that can restore function topatients with a chronic stroke-induced motor deficit. Thus, creating and vetting a technical infrastructure to enableremote acquisition/analysis of a patient's brain signals and their motor function is essential to achieving this goal.The objective of this proposal is to create a mail-delivered, internet-connected system that enables home-basedEEG screening for BCI-rehab candidacy and remote motor assessment of upper extremity response to BCI-rehab treatment. Our central hypothesis is that fully remote assessment, enrollment, and treatment of chronicstroke patients with an upper extremity motor deficit with the use of a BCI-controlled robotic hand exoskeletonwill demonstrate significant improvement in hand function. Thus, the rationale is that enabling patients to beeffectively screened, treated and monitored at home removes the need for patients to travel to health careenvironments and thus enables a much larger population to access this technology. With extensive experiencein stroke-BCI and home-based care [3], we are well prepared to pursue the objective of this proposal with thefollowing Specific Aims: 1) Create a home-based EEG screening system for chronic stroke patients to determinecandidacy for BCI rehabilitation of upper extremity motor deficit, 2) Create a home-based system for performingphysical motor assessments that are equivalent to standard in-person Fugl-Meyer (FM) assessment of upperextremity function, 3) Define the accuracy of home-based Fugl-Meyer (FM) assessment against gold standardin-person FM assessment, and 4) Define the efficacy of fully remote home-based BCI therapy in chronichemiparetic subcortical stroke patients. This project is innovative because 1) it represents a departure from thestatus quo by expanding the role the unaffected hemisphere can play in BCI-mediated stroke rehabilitation and2) the focus on full course of treatment (screening, treatment and monitoring) occurring in the home significantlydeparts from the commercial models of how advanced BCI-mediated rehabilitation is delivered. This project willleverage the core Neurolutions BCI rehabilitation technology, the IpsiHand, which was recently given aBreakthrough Device designation by the FDA. The proposed research will be significant because the creation ofan integrated system that can assess and treat chronic stroke patients remotely will radically increase accessand therapeutic benefit to a much larger percent of this underserved population. Collectively, the successfulexecution of this project will reduce the personal and social burden of stroke for millions of Americans.

Public Health Relevance Statement:
Project Narrative The proposed research is relevant to public health because developing a technology solution that enhances access to neuroprosthetic rehabilitation of chronic stroke will fundamentally expand the number of patients that can be treated with these advanced approaches to induce a functional recovery. Thus, the proposed research is relevant to the NINDS mission, which is to reduce the burden of the neurologic disease of stroke.

Project Terms: