MedTrace Logo

National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

NCT05965713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2025-12-15

No results posted yet for this study

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).

Conditions

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

Interventions

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 and at 12 weeks completion of IpsiHand use.

OTHER

Standard of Care - Home Exercise Program for Upper Extremity

Subjects will receive a customized standard of care home exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Neurolutions, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexandre Carter, MD, PhD · Washington University in Saint Louis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-09-12
Completion
2025-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05965713 on ClinicalTrials.gov