National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

Description

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).

Conditions

Stroke, Hemiparesis, Spasticity as Sequela of Stroke, Brain Computer Interface

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Study Overview

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Study Details

Study overview

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).

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

National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Neurolutions, Saint Louis, Missouri, United States, 63110

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neurolutions, Inc.,

Study Record Dates

2025-10-31