Trials Sponsors Conditions Drugs Pricing

Conditions

Blindness,Acquired

Outcome Measures

Primary Outcomes (3)

Stimulation level required to elicit visual phosphene
Quantitative outcome. Direct brain stimulation to reproduce visual phenomena has not been done. There are no predesigned outcome measures. For this outcome measure, we will determine how much stimulation (in amps) is required to induce a perception of vision.
6 months
Characterization of stimulation-induced visions
Descriptive outcome. Subjects will be asked to describe the type of visual perception that is induced by direct brain stimulation.
6 months
Spatial localization of stimulation to produce visual phenomena with direct cortical stimulation.
Anatomic outcome. No predetermined outcome scale exists. We will assess patients and the sites of brain stimulation to determine which areas of the brain produce reliable visual phenomena when stimulated.
6 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

Subjects will be implanted to assess the feasibility of stimulating visual cortex to restore vision in blind volunteers.

Procedure: Surgical device implant in brain

Interventions

Surgical device implant in brainProcedure

Neuropace RNS implant ove visual cortex

Treatment Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 74 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject is blind (i.e. bare light perception or no light perception in both eyes).
Subject has a history of useful form vision.

Sponsors & Collaborators

University of California, Los Angeles
Otherlead

Study Sites (1)

UCLA Department of Neurosurgery

Los Angeles, California, 90095, United States

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Ausaf Bari, MPH
University of California, Los Angeles
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 22, 2016

Study Start

August 2016

Actual (reported)

Primary Completion

December 31, 2026

Estimated

You may not qualify if:

Subject is blind due to cortical etiology (e.g. injury to the visual cortex).
Subject is eligible for another commercially available vision restoration therapy (e.g. retinal prosthesis).
Subject is at high risk for surgical complications such as active systemic infection, coagulation disorders (such as the use of anti-thrombotic therapies) or platelet count below 100,000.
Subject has history of bleeding or immune compromise.
Subject is taking chronic anticoagulants or antiplatelet agent or subject has an abnormally elevated preoperative coagulation profile (either PTT or PT/INR).
Subject has had prior craniotomy or brain surgery.
Subject has evidence of active intracranial disease that would preclude elective neurosurgical intervention, such as unruptured intracranial aneurysm or brain tumor, or aberrant visual cortex anatomy, such as prior stroke or arteriovenous malformation.
Subject has a significant abnormality on preoperative brain MRI
Subject has a prior history of seizures or epilepsy.
Subject has Parkinson's disease
Subject has a prior history of serious head injury with loss of consciousness.
Subject has a progressive central nervous system disease.
Subject has history of implant-related infection.
Implantation of the investigational device would present unacceptable risk.
Subject requires or is likely to require any of the following medical procedures while implanted with the NeuroPace RNS System: MR imaging, diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS). These medical procedures are contraindicated for patients with an implanted RNS® System. Energy from these procedures can be sent through the implanted brain stimulation system and cause permanent brain damage which may cause severe injury, coma, or death. Brain damage can occur from any of the listed procedures even if the RNS® Neurostimulator is turned off or if the Leads are not connected to the Neurostimulator, and can occur even if the Neurostimulator has been removed and any Leads (or any part of a Lead) or the cranial prosthesis remain. Refer to the Contraindications section of the RNS System User Manual for further details.
+14 more criteria

Feasibility of Stimulating the Visual Cortex in Blind

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Treatment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Treatment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations