Clinical trial NCT04338971: Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes
Official title: Ipsihand Device Use in Stroke Patients to Assess Motor Recovery of the Upper Extremity and Functional Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Brain-Computer Interface
Lead sponsor: Neurolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by EEG electrodes. The system also utilizes a tablet interface to provide therapy instructions to the patient.

Detailed description: Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.

Eligibility criteria: Inclusion Criteria:

* 6-months or more post stroke
* Presentation of upper extremity hemiparesis or hemiplegia
* Participants must english speaking
* Demonstrate intact cognition to provide informed consent
* Botox injections are allowed, and must continue regimen at regular intervals throughout the study

Exclusion Criteria -

* Not active in another clinical study
* Not receiving formal therapy for the upper extremity
* No use of other modalities or technologies to the upper extremity
* Cognitive Impairment: Short Blessed Test Score 9 or above
* Significant Spasticity: Modified Ashworth Scale score 3 or more at the elbow
* Significant Hemispatial Neglect: Mesulam Cancellation Test 3 or more unilaterally
* Insufficient Strength: Motricity Index score for shoulder abduction 18 - Any contractors of the affected upper extremity that would not allow the IpsiHand robotic exoskeleton to be worn comfortably and/or safely for device use

Primary outcomes:
measure: Fugl-Meyer Assessment - Upper Extremity
timeFrame: "Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score.
Secondary outcomes:
measure: Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks
timeFrame: Change in AMAT score (points) from Baseline to 12 Weeks
Other outcomes:
Locations:
city: Santa Cruz
country: United States
facility: Neurolutions
state: California
city: Saint Louis
country: United States
facility: Neurolutions
state: Missouri
Study officials:
affiliation: Principal Investigator
name: Alexandre Carter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.