Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

NCT04338971 | Completed Results DMC FDA Device

• 1 other identifier: Ipsihand Use in Chronic Stroke
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Rehabilitation; Brain-Computer Interface

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - Upper Extremity

  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity.

  "Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score.

Secondary Outcomes (1)

• Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks

  Change in AMAT score (points) from Baseline to 12 Weeks

Study Arms (1)

IpsiHand Device

EXPERIMENTAL

All participants will receive treatment with the IpsiHand Device.

Device: IpsiHand Therapy

Interventions

IpsiHand Therapy 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 hometherapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.

IpsiHand Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurolutions, Inc.: lead

Study Sites (2)

Neurolutions

Santa Cruz, California, 95060, United States

Location

Neurolutions

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• 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

• Rustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Rehabilitation in Chronic Stroke. Neurorehabil Neural Repair. 2025 Jan;39(1):74-86. doi: 10.1177/15459683241287731. Epub 2024 Sep 30.

  PMID: 39345118 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Innovation
• Organization: Neurolutions

innovation@kandu.com

6027033730

Study Officials

• Alexandre Carter, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: April 8, 2020
• Study Start: May 5, 2017
• Primary Completion: September 28, 2020
• Study Completion: October 9, 2020
• Last Updated: April 17, 2026
• Results First Posted: January 18, 2022

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)