Status:
RECRUITING
PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss Due to Stroke, Traumatic Brain Injury, or Brain Surgery
Lead Sponsor:
NeuroAEye LLC
Conditions:
Homonymous Hemianopsia
Homonymous Quadrantanopia
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
This is a research study to evaluate the effectiveness of the PAVE (Parallactic Visual-Field Enhancement) System for the treatment of chronic visual field loss due to stroke, traumatic brain injury, o...
Detailed Description
This clinical investigation will focus on patients with chronic visual field loss following a cerebrovascular accident (CVA), a traumatic brain injury (TBI), or surgery of the brain. The CVA and TBI a...
Eligibility Criteria
Inclusion
- This study will include patients at least 6 months after the CVA or TBI or brain surgery event and up to five (5) years after onset
- The patients shall have a definitive diagnosis of homonymous hemianopia or quadrantanopia or generalized constriction.
Exclusion
- Presence of any physical, neurological, or mental disability that would interfere with receiving the therapy.
- Concurrent use of another visual therapy
- Concurrent use of medications judged to affect training (amphetamines, dopamine, etc.)
- Presence of ocular or neurological conditions that would interfere with training or cause a visual impairment including no residual vision, disorders of the eye, non-optic nerve heteronymous visual field defects
- Insufficient fixation ability
- Use of life supporting external medical device such as infusion pumps, ventricular assist devices, etc.
- Presence of active implantable medical device including but not limited to cardiac pacemakers, defibrillators, nerve stimulators, cochlear implants, etc.
- Subjects with known photosensitive epilepsy.
- Subjects with chronic active infections on the head and face should be excluded from the study
- Patients with known immune disorders for whom an infection could be life threatening should be excluded from the study.
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07185971
Start Date
September 22 2025
End Date
August 1 2026
Last Update
November 17 2025
Active Locations (1)
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1
Dr. D. M. Fitzgerald & Associates
Cedar Rapids, Iowa, United States, 52404