IpsiHand System for Rehabilitation of the Arm and Hand After Stroke

NCT ID: NCT04123808

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2020-06-30

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.

Detailed Description

This trial aims to assess the effectiveness of the NeuroLutions Upper Extremity Rehabilitation System, known as IpsiHand, on functional motor recovery and neuroplasticity for chronic stroke survivors with hemiparesis (N=27). The IpsiHand system involves a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis. Participants will complete 16-32 weeks of home therapy with the IpsiHand system.

Conditions

Stroke; Hemiparesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IpsiHand Treatment

All participants will receive treatment with IpsiHand device

Group Type: EXPERIMENTAL

IpsiHand Treatment

Intervention Type: 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.

Interventions

IpsiHand Treatment

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurolutions, Inc.

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Joel Stein, MD

Professor and Chair of the Department of Rehabilitation and Regenerative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

References

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.

Reference Type: BACKGROUND

PMID: 28550098 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29761128 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24136129 (View on PubMed)

Other Identifiers

AAAS4076

Identifier Type: -

Identifier Source: org_study_id