Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

NCT05965713 | Completed Results FDA Device

• 2 other identifiers: BCI-REHAB4R44HD105579-02
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

BCI-REHAB was a randomized clinical trial comparing an at-home brain-computer interface therapy system versus an at-home exercise program for upper-extremity rehabilitation in the chronic phases of stroke. The purpose of the trial was to evaluate the efficacy of BCI-based therapy tested against standard exercise therapy and assess the potential for meaningful motor improvement in the home environment.

Conditions

Stroke; Hemiparesis; Spasticity as Sequela of Stroke; Brain Computer Interface; Chronic Stroke Survivors With Plegic Hand

Keywords

Neurolutions; IpsiHand

Outcome Measures

Primary Outcomes (1)

• Upper Extremity Fugl-Meyer (UEFM)

  Assessment tool of upper extremity motor function. Lowest score 0, highest score 66.

  12 weeks

Study Arms (2)

Home Based BCI Rehabilitation (BCI)

EXPERIMENTAL

Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks.

Device: Neurolutions IpsiHand Upper Extremity Rehabilitation System

Home Exercise rehabilitation regimen Program (HEP)

ACTIVE COMPARATOR

The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.

Other: Home Exercise rehabilitation regimen Program (HEP)

Interventions

Neurolutions IpsiHand Upper Extremity Rehabilitation System DEVICE

Electroencephalography (EEG)-driven upper extremity powered exerciser. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.

Home Based BCI Rehabilitation (BCI)

Home Exercise rehabilitation regimen Program (HEP) OTHER

The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.

Home Exercise rehabilitation regimen Program (HEP)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurolutions, Inc.: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

Related Links

• Using ipsilateral motor signals in the unaffected cerebral hemisphere as a signal platform for brain-computer interfaces in hemiplegic stroke survivors
• A retrospective analysis of post-stroke rehabilitation with real world use of brain-computer interface
• Upper limb motor recovery in chronic stroke-longitudinal aggregate analysis from control group outcomes

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Seth Wilk, PhD, Chief Innovation Officer
• Organization: Neurolutions, Inc.

innovation@neurolutions.com

1 833 438 4774

Study Officials

• Alexandre Carter, MD, PhD

  Washington University in Saint Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 Randomization

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 28, 2023
• Study Start: October 1, 2023
• Primary Completion: September 12, 2025
• Study Completion: October 30, 2025
• Last Updated: August 12, 2026
• Results First Posted: August 12, 2026

Record last verified: 2026-07

Locations

US (1)