Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis; Spasticity as Sequela of Stroke; Chronic Stroke Survivors With Plegic Hand; Brain Computer Interface
• Intervention / Treatment: Device: Neurolutions IpsiHand Upper Extremity Rehabilitation System; Other: Home Exercise rehabilitation regimen Program (HEP)

Detailed Description

After meeting the inclusion criteria, all participants underwent an EEG evaluation to ensure that EEG features sufficient for device control could be detected. Participants who met the inclusion/exclusion criteria and passed the EEG test were randomly assigned (1:1) to either home-based BCI rehabilitation (BCI) or a Home Exercise rehabilitation regimen Program (HEP).

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. During the therapy sessions, the system would guide the patient through a series of routines in which they would imagine opening and closing their affected hand. At the instant the BCI detected sensorimotor cortex EEG spectral features associated with imagined ipsilateral hand movements, the handpiece opened and closed the participant's hand in a three-finger pinch grip.

Participants did not receive occupational or physical therapy services while participating in the self-directed BCI Therapy.

Participants allocated to the HEP control group received a structured home exercise program designed to control for non-specific motor and sensory engagement associated with the intervention. They completed an in-person baseline assessment of function and an HEP training session with an OT. 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.

The Primary outcome assessment was the in-person Upper Extremity Fugl-Meyer (UEFM) completed on day 1 (baseline) and after 12 weeks of participation.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University in Saint Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Based BCI Rehabilitation (BCI); 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; 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.
Active Comparator: Home Exercise rehabilitation regimen Program (HEP); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity Fugl-Meyer (UEFM)	Assessment tool of upper extremity motor function. Lowest score 0, highest score 66.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurolutions Upper Extremity Remote Assessment (Remote Digital Fugl Meyer)	Shortened and validated digitized assessment tool derived from the Fugl-Meyer Long form developed by Neurolutions of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Embedded into study software. Lowest score 0, highest score 66.	Baseline, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week completion assessment
Pinch force (Dynamometer)	Evaluation of two and three point pinch strength via dynamometry; lowest score= 0lbs, highest score =150lbs	Baseline and 12 week completion assessment
Gross Grasp (Dynamometer)	Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs	Baseline and 12 week completion assessment
Motricity Index (Shoulder, Elbow, Pinch)	Evaluation of motor strength on the shoulder, elbow and pinch. Scored on a 0-5 scale. 0 being totally absent muscle strength and range of motion, 5 bring full strength and range of motion of limb.	Baseline and 12 week completion assessment
Western Aphasia Battery (Bedside Record Form)	Assessment of language function for classification of aphasia following a stoke.	Baseline and 12 week completion assessment
Timed Up and Go Test (TUG)	Assessment functional mobility and fall risk	Baseline and 12 week completion assessment
10 Meter Walking Test	Assessment functional mobility, speed of mobility and fall risk	Baseline and 12 week completion assessment
Arm Motor Ability Test (4 Subtests Only)	Assessment to evaluate upper extremity function in activities of daily living	Baseline and 12 week completion assessment
Trail Making Test- Parts A and B	Assessment of general cognitive function specifically assesses working memory, visual processing, visuospatial skills, selective and divided attention.	Baseline and 12 week completion assessment
Modified Rankin Scale	A widely used assessment tool for measuring the degree of disability or dependence in people who have experienced stroke or other neurological conditions. The sale ranges from 0 (no symptoms) to 6 (death), and is commonly used as a primary outcome measure in stroke clinical trials.	Baseline and 12 week completion assessment
PHQ-9	A widely used assessment tool for self reporting of depression. This assessment is scored from 0-27. 0-4: Minimal or no depression. 5-9: Mild depression. 10-14: Moderate depression. 15-19: Moderately severe depression. 20-27: Severe depression.	Baseline and 12 week completion assessment
Zarit Burden Interview (ZBI)	Widely used questionnaire designed to assess the level of burden experienced by caregivers	Baseline and 12 week completion assessment
The Barthel Index	Assessment tool that measures a person's functional independence in activities of daily living and self-care	Baseline and 12 week completion assessment

Collaborators and Investigators

• Sponsor: Neurolutions, Inc.
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Alexandre Carter, MD, PhD, Washington University in Saint Louis

Publications and helpful links

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): September 12, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Neurolutions; IpsiHand
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Paresis
• Other Study ID Numbers: BCI-REHAB; 4R44HD105579-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data Supplement is available upon written request per NIH guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No