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

NCT07147881 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-08-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Neurolutions, Inc.

    lead INDUSTRY

Principal Investigators

  • Seth Wilk, PhD · Neurolutions, Inc.

  • Lee Fleisher, MD

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-12-01
Completion
2028-01-01
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07147881 on ClinicalTrials.gov