IpsiHand System for Rehabilitation of the Arm and Hand After Stroke

Stroke Clinical Trial

Official title:

Dosing Effects of an Upper Extremity Rehabilitation Program Using a Brain-Computer Interface Mediated Robotic Hand Orthosis for Chronic Stroke Patients: IpsiHand System

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04123808
• Other study ID #: AAAS4076
• Status: Withdrawn
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Neurolutions, Inc.

References & 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. — View Citation

Cervera MA, Soekadar SR, Ushiba J, Millán 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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Action Research Arm Test	The ARAT is a scale that measures activity participation of the arm. There are 19 items that several types of grasps, grips, pinches, and gross movements of the arm and hand. Each item is scored from 0-3, with a maximum total score of 57. Higher scores indicate better performance.	Baseline through 3 months post no device use
Secondary	Box and Block Test	The Box and Block Test measures the number of blocks a participant can pick up and place over a patrician in 1 minute. The number of blocks successfully moved are counted and a higher number indicates better performance.	Baseline through 3 months post no device use