National 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

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).

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis; Spasticity as Sequela of Stroke; Brain Computer Interface
• Intervention / Treatment: Device: Neurolutions IpsiHand System; Other: Standard of Care - Home Exercise Program for Upper Extremity

Detailed Description

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor impaired stroke survivors. This ultimate goal is to develop a system that allows for enhanced functional capability and works consistently over a long-term basis and is accessible remotely no matter location or access to healthcare. In developing a new rehabilitation method, the researchers hope to create a system that allows for closed loop feedback through a robotic hand orthosis on the motor impaired side of stroke patients in response to intended movements of the muscles. The method, if successful, would represent an ideal, non-invasive method of promoting motor learning and recovery in stroke survivors. The ability to operate robotic hand orthosis using electrical signals of the brain is rapidly leaving the realm of science fiction and becoming a realistic goal of the clinical community. The current advances in BCI controlled neuroprosthetics could have immeasurable influence on adult patients with severe motor impairments from stroke. Even further on the horizon the insights developed from such work could substantively alter the way all stroke patients are treated and rehabilitated.

• 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: BCI treatment Group using the IpsiHand; Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Subjects will undergo an EEG screening protocol to ensure that a consistent control signal will be present to control the IpsiHand device. After an EEG screening session is complete, the participants screening data will be analyzed to ensure that sufficient cortical signals are present. Randomization for assignment to group 1 or 2 will then occur. Once assigned to group 1, if consistent signals are found, the participant will then continue to Phase 2. Phase 2: Group 1 subjects will be provided with a Neurolutions IpsiHand BCI system, which combines a novel powered exoskeleton with a commercial EEG amplifier and active electrode system. The exoskeleton opens and closes the patient's hand in a three-finger pinch grip. Patients will use the BCI system on a minimum of 5 days per week for 12 weeks. Patients will complete five or more 10-minute runs of the BCI task per day.	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.
Experimental: Standard of Care - Home Exercise Program for Upper Extremity; Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Once randomized, the participant will be assigned to group 2 to begin standard of care treatment at home. Phase 2: After being assigned to Group 2, subjects will serve as the control group in the study. Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks to control for the non-specific motor and sensory effects of BCI training. To help ensure compliance with the at-home portion of the protocol in the control group, participants will receive daily virtual monitoring from the study clinical specialist.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer - Upper Extremity (UEFM) , Manual Long Form	Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.	Assessed at baseline visit and at completion of study

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

• A variables associated with occupational and physical therapy stroke rehabilitation utilization and outcomes
• Inequities in access to inpatient rehabilitation after stroke: an international scoping review
• Clinical practice. Rehabilitation after stroke
• Brain-Computer Interface in Stroke Rehabilitation
• Think to move: a neuromagnetic brain-computer interface (BCI) system for chronic stroke
• Feasibility of a new application of noninvasive Brain Computer Interface (BCI): a case study of training for recovery of volitional motor control after stroke
• Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke
• An evaluation framework for a rural home-based telerehabilitation network
• Disparities in postacute stroke rehabilitation disposition to acute inpatient rehabilitation vs. home: findings from the North Carolina Hospital Discharge Database
• Barriers to care among racial/ethnic groups under managed care
• Stroke patients' and carers' perception of barriers to accessing stroke information
• Rehabilitation with poststroke motor recovery: a review with a focus on neural plasticity
• Brain-computer interface with somatosensory feedback improves functional recovery from severe hemiplegia due to chronic stroke
• Efficacy of brain-computer interface-driven neuromuscular electrical stimulation for chronic paresis after stroke

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 (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

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: National Remote IpsiHand Study; 4R44HD105579-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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