National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

NCT05965713 | Completed FDA Device

• 2 other identifiers: National Remote IpsiHand Study4R44HD105579-02
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neurolutions; IpsiHand

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Neurolutions Upper Extremity Remote Assessment (Remote Digital Fugl Meyer)

  Baseline, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week completion assessment

• Pinch force (Dynamometer)

  Baseline and 12 week completion assessment

• Gross Grasp (Dynamometer)

  Baseline and 12 week completion assessment

• Motricity Index (Shoulder, Elbow, Pinch)

  Baseline and 12 week completion assessment

• Western Aphasia Battery (Bedside Record Form)

  Baseline and 12 week completion assessment

Study Arms (2)

BCI treatment Group using the IpsiHand

EXPERIMENTAL

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

Standard of Care - Home Exercise Program for Upper Extremity

EXPERIMENTAL

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

Interventions

Neurolutions IpsiHand System DEVICE

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.

BCI treatment Group using the IpsiHand

Standard of Care - Home Exercise Program for Upper Extremity OTHER

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.

Standard of Care - Home Exercise Program for Upper Extremity

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

• 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

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

Study Officials

• Alexandre Carter, MD, PhD

  Washington University in Saint Louis

  PRINCIPAL INVESTIGATOR

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: Study staff will screen participants virtually or in person for eligibility after completing the informed consent process and documentation. After screening for study eligibility has occurred, the initial EEG screening will take place for all individuals who meet the criteria for the study as to ensure no preference to subjects with optimal signals for use of the IpsiHand. Once EEG screenings have been completed, the participant will be randomly assigned to Group 1 (BCI treatment) or Group 2 (standard of care treatment group). Each group will complete a daily therapy regimen. In Group 1 (BCI group)- will complete daily BCI therapy. In Group 2 (standard of care)- individuals will complete standard of care therapy program daily for 12 weeks provided by an occupational therapist.

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: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)