IpsiHand System for Rehabilitation of the Arm and Hand After Stroke

NCT04123808 | Withdrawn FDA Device

• 1 other identifier: AAAS4076
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess whether the NeuroLutions Upper Extremity Rehabilitation System (known as IpsiHand) will help stroke patients regain strength and functional movements in their arm. The IpsiHand system involves using a hand robotic device that is controlled by brain waves, known as a Brain-Computer Interface (BCI). By using the device, participants will be harnessing brainwaves from the side of their brain not affected by stroke to control the robotic device on the hand that is weaker from the stroke.

Conditions

Stroke; Hemiparesis

Keywords

Stroke; Hemiparesis; Rehabilitation; Upper Extremity; Neurological Rehabilitation; Neuronal Plasticity; Brain-Computer Interfaces; Robotics

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity

  The Fugl-Meyer is a scale that measures capacity of the arm. There are 33 items that evaluate reflexes, active movement, grasp patterns, speed, and coordination of the arm and hand. Each item is scored from 0-2, with a maximum total score of 66. Higher scores indicate better performance.

  Baseline through 3 months post no device use

Secondary Outcomes (2)

• Action Research Arm Test

  Baseline through 3 months post no device use

• Box and Block Test

  Baseline through 3 months post no device use

Study Arms (1)

IpsiHand Treatment

EXPERIMENTAL

All participants will receive treatment with IpsiHand device

Device: IpsiHand Treatment

Interventions

IpsiHand Treatment DEVICE

The IpsiHand system utilizes a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis donned on the affected upper extremity as participants are guided through a rehabilitation program on a tablet. Participants will complete 16-32 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 3 months post no-device use, to track progress.

IpsiHand Treatment

Eligibility Criteria

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

You may qualify if:

• Diagnosis of stroke(s), with most recent stroke at least 6 months prior to study start (can be ischemic or hemorrhagic)
• PROM: Full extension of digits 2 and 3 at MPs, PIPs, and DIPs
• English speaking
• Intact cognition to provide informed consent
• Intact language skills to comprehend and follow directions
• Experiencing difficulty performing ADLs with affected upper limb
• Upper extremity Botox allowable, but not required
• Botox users must continue regimen at regular intervals for duration of study
• Botox users will provide clinic note for each injection (date, dose, and muscle location)
• Botox + Study Schedule
• At study initiation, Botox injection will occur between 3-7 days prior to baseline measurement and initiation of device use
• Repeat Botox injections must be completed at least 3 days prior to any administration of the outcome measures

You may not qualify if:

• Concurrent participation in another study
• Co-morbid orthopedic condition/pain limiting functional use of the impaired upper limb
• History of neurological disorder other than stroke
• Botox user unable to comply with above noted requirements
• Ongoing physical or occupational therapy addressing the upper limb
• Ongoing electric stimulation or other rehabilitative devices (e.g. robotics, virtual reality) to upper limb
• Cognitive impairment: Short Blessed Test Score 9
• Significant spasticity: Modified Ashworth Scale score 3 at the elbow
• Significant hemispatial neglect: Mesulam Cancellation Test 3 unilaterally
• Insufficient Strength: Motricity Index score for shoulder abduction 18
• Significantly impaired sensation of impaired upper limb: National Institutes of Health Stroke Scale - Item 8 (Sensory) score of 2
• History of cranioplasty
• History of seizure disorder
• No changes to usual exercises, splint use, or oral baclofen/anti-spasticity medication use during trial

Sponsors & Collaborators

• Columbia University: lead
• Neurolutions, Inc.: collaborator

Related Publications (3)

• Bundy DT, Souders L, Baranyai K, Leonard L, Schalk G, Coker R, Moran DW, Huskey T, Leuthardt EC. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke. 2017 Jul;48(7):1908-1915. doi: 10.1161/STROKEAHA.116.016304. Epub 2017 May 26.

  PMID: 28550098 BACKGROUND

• Cervera MA, Soekadar SR, Ushiba J, Millan JDR, Liu M, Birbaumer N, Garipelli G. Brain-computer interfaces for post-stroke motor rehabilitation: a meta-analysis. Ann Clin Transl Neurol. 2018 Mar 25;5(5):651-663. doi: 10.1002/acn3.544. eCollection 2018 May.

  PMID: 29761128 BACKGROUND

• Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.

  PMID: 24136129 BACKGROUND

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

• Joel Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: An occupational therapist independent to the study will review and score 2 outcome measures (Fugl-Meyer and Action Research Arm Test). The study coordinator will randomize the order of the videos for each participant, so that the outcome assessor will not know which time point they are scoring. In other words, the video-outcome assessor will be blinded to the order of the assessments as they are scoring them but will not be blinded to the intervention as all participants will be receiving the same intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of the Department of Rehabilitation and Regenerative Medicine

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: December 2, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share