Blindness,AcquiredNCT02747589
Feasibility of Stimulating the Visual Cortex in Blind
A study testing Surgical device implant in brain in people with Blindness,Acquired, run by University of California, Los Angeles at 1 site in United States.
Trial summary
In this study, the investigators intend to evaluate the use of a commercially available neurostimulator system, NeuroPace RNS System to stimulate the visual cortex. The NeuroPace RNS System has a proven record of safety and reliability was approved by the FDA in November 2013. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Blindness,Acquired
- What is being tested?
- Surgical device implant in brain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is blind (i.e. bare light perception or no light perception in both eyes).
- Subject has a history of useful form vision.
- Subject is between the age of 18-74.
- Subject resides within 2 hours distance (by ground transportation) of the investigational site.
- Subject is (a) male or (b) a female of childbearing potential with a negative pregnancy test who is using a reliable method of contraception or is at least two years post-menopause.
- Subject is able to complete regular office and telephone appointments per the protocol requirements.
- Subject is medically fit for neurosurgical intervention.
- Subject is considered a good candidate to be implanted with the investigational device.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
- Subject is implanted with any neurostimulation or neuromodulation device in the head including, but not limited to cochlear implant, deep brain stimulator, or auditory brain implant.
- Subject has a clinically significant or unstable medical condition including uncontrolled systemic hypertension with values above 170/100; cardiac or pulmonary disease; uncorrected coagulation abnormalities; diabetes; or any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
- Subject has had an alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response.
- Subject has uncontrolled chronic pain.
- Subject has significant neurocognitive impairment in memory domain (based on MoCA-BLIND <18 or WAIS-IV <80, described below).
- Subject had moderate or severe depression, as determined by a score of at least 17 on the HAMD.
- Subject has had a suicide attempt in the last two years, presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview), or a "yes" answer to any one of the ten suicidal ideation and behavior questions on the C-SSRS.
- Subject has a disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
- Cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease
- Psychiatric disease including diagnosed forms of depression
- Does not speak a principal language associated with the region
- Deafness or selective frequency hearing loss that prevents adequate communication with the researchers.
- Subject is pregnant or planning on becoming pregnant in the next year.
- Subject is enrolled in another therapeutic investigational drug or device trial
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Department of Neurosurgery
Los Angeles, California, 90095
About this study
Official title: Study to Assess the Feasibility of Stimulating the Visual Cortex in Blind Volunteers
In this study, the investigators intend to evaluate the use of a commercially available neurostimulator system, NeuroPace RNS System to stimulate the visual cortex. The NeuroPace RNS System has a proven record of safety and reliability was approved by the FDA in November 2013. The RNS System is indicated for use in patients with epilepsy and includes a skull implanted neurostimulator. No modification to the RNS System is required for this study. This study will use this device to better understand the effect of stimulation on the visual parts of the brain.
The main purposes of this study are to confirm the desired location to implant a device in the visual cortex, determine the amount of energy needed to elicit vision, and assess the nature of the vision that is produced. This information is important to have early in the process of designing a visual cortical prosthesis that could eventually be used for commercial use.
- Conditions
- Blindness,Acquired
- Being tested
- Surgical device implant in brain
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical device implant in brainProcedure or surgery
Neuropace RNS implant ove visual cortex
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects will be implanted to assess the feasibility of stimulating visual cortex to restore vision in blind volunteers. Receives: Procedure: Surgical device implant in brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startAug 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blindness,AcquiredStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ausaf A. Bari, MD, PhD, University of California, Los Angeles
- Investigators
- Ausaf Bari, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747589
- Sponsor's protocol ID
- BlindStim
- Status last verified
- Nov 2025
- First submitted
- 14 Apr 2016
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Feasibility of Stimulating the Visual Cortex in Blind Volunteers
- ClinicalTrials.gov ID
- NCT02747589
- Acronym / sponsor ID
- BlindStim
- Conditions
- Blindness,Acquired
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators intend to evaluate the use of a commercially available neurostimulator system, NeuroPace RNS System to stimulate the visual cortex. The NeuroPace RNS System has a proven record of safety and reliability was approved by the FDA in November 2013. The RNS System is indicated for use in patients with epilepsy and includes a skull implanted neurostimulator. No modification to the RNS System is required for this study. This study will use this device to better understand the effect of stimulation on the visual parts of the brain.
The main purposes of this study are to confirm the desired location to implant a device in the visual cortex, determine the amount of energy needed to elicit vision, and assess the nature of the vision that is produced. This information is important to have early in the process of designing a visual cortical prosthesis that could eventually be used for commercial use.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Surgical device implant in brainSubjects will be implanted to assess the feasibility of stimulating visual cortex to restore vision in blind volunteers. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is blind (i.e. bare light perception or no light perception in both eyes).
- Subject has a history of useful form vision.
- Subject is between the age of 18-74.
- Subject resides within 2 hours distance (by ground transportation) of the investigational site.
- Subject is (a) male or (b) a female of childbearing potential with a negative pregnancy test who is using a reliable method of contraception or is at least two years post-menopause.
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical device implant in brainNeuropace RNS implant ove visual cortex | Procedure or surgery | Treatment Group |
Primary outcome
Stimulation level required to elicit visual phosphene
Time frame: 6 months
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.
Characterization of stimulation-induced visions
Time frame: 6 months
Descriptive outcome. Subjects will be asked to describe the type of visual perception that is induced by direct brain stimulation.
Spatial localization of stimulation to produce visual phenomena with direct cortical stimulation.
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ausaf Bari, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical device implant in brain in people with Blindness,Acquired, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulation level required to elicit visual phosphene (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.