Prospective Real-World Evidence Study of the IpsiHand® System in Adult Stroke Survivors

NCT07147881 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: RWE_002
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study focuses on monitoring real-world customers who have been prescribed the IpsiHand® as part of their rehabilitation post-stroke. This study aims to evaluate their progress over time, assessing motor recovery, functional independence in activities of daily living (ADLs), caregiver burden, and health economic outcomes.

Conditions

Stroke; Hemiparesis After Stroke; Brain Computer Interface

Keywords

Neurolutions; IpsiHand; Stroke; Hemiparesis after stroke; BCI

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer - Upper Extremity (FM-UE) , Manual Long Form

  Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.

  Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.

Secondary Outcomes (4)

• The Barthel Index

  Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.

• Zarit Caregiver Burden Scale (ZBI)

  Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.

• Patient Specific Functional Scale (PSFS)

  Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.

• Euro-QOL5D5L

  Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.

Study Arms (1)

Adult stroke patients with upper extremity hemiparesis.

Chronic Stroke Patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation with use of the IpsiHand® System.

Device: IpsiHand

Interventions

IpsiHand DEVICE

IpsiHand is a therapeutic device that uses a brain-computer interface system which detects neural signals associated with motor intent and translates them into assisted hand movements in individuals with upper extremity impairment following a stroke.

Also known as: IpsiHand Therapy, BCI Therapy

Adult stroke patients with upper extremity hemiparesis.

Eligibility Criteria

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

Study Population

Chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing rehabilitation using the IpsiHand® System.

You may qualify if:

• Adult age 18-85 years.
• Diagnosis of stroke six or more months prior with upper extremity weakness.
• Has received an IpsiHand® system as a commercial customer for stroke rehabilitation.

You may not qualify if:

• Severe cognitive impairment that would impede utilization of IpsiHand®
• Any contraindications to IpsiHand® device use
• Inability to comprehend English

Sponsors & Collaborators

• Neurolutions, Inc.: lead

Related Publications (3)

• Rustamov N, Humphries J, Carter A, Leuthardt EC. Theta-gamma coupling as a cortical biomarker of brain-computer interface-mediated motor recovery in chronic stroke. Brain Commun. 2022 May 25;4(3):fcac136. doi: 10.1093/braincomms/fcac136. eCollection 2022.

  PMID: 35702730 BACKGROUND

• Rustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Recovery in Chronic Stroke. medRxiv [Preprint]. 2023 Aug 28:2023.08.26.23294320. doi: 10.1101/2023.08.26.23294320.

  PMID: 37693482 BACKGROUND

• 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

Related Links

• FDA De Novo Authorization

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Seth Wilk, PhD

  Neurolutions, Inc.

  PRINCIPAL INVESTIGATOR

• Lee Fleisher, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Souders, MOT, OTR/L, CBIS, CSRS

CONTACT

213-286-3323; innovation@kandu.com

Seth Wilk, PhD

CONTACT

213-286-3323; innovation@kandu.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share