NCT07147881

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Neurolutions, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

IpsiHand® is an FDA-authorized, non-invasive, BCI-based device that is indicated for use in chronic stroke patients (≥ 6 months post stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity. Through utilization of EEG signals from the unaffected side of the brain, the device enables stroke survivors to control a robotic hand orthosis, facilitating functional reorganization of the brain and improved motor recovery.

Conditions

• Stroke
• Hemiparesis After Stroke
• Brain Computer Interface

Interventions

Type	Name	Description
DEVICE	IpsiHand	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2025-08-29
• Last updated: 2025-08-29

Regulatory

• FDA-regulated device study