NCT04634383

Brief Summary

The purpose of this study is to determine the feasibility of producing artificial vision in persons with blindness. Study participants will have wireless electrical stimulators implanted into the cortical vision processing areas of their brains. The ability of the participants to perceive artificial vision in response to electrical stimulation will be assessed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

October 12, 2020

Last Update Submit

January 9, 2022

Conditions

Ocular InjuryOptic Nerve DiseasesPhotoreceptor DegenerationBlindness,Acquired

Keywords

BlindnessVisual ProsthesisElectrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • To test the safety of the WFMA-based cortical interface.

    Safety is defined as the number of adverse events occurring over the study period due to surgical complications or use of the WFMA device.

    From two-weeks post-op to end of device use, up to 3 years.

Secondary Outcomes (1)

  • To test the efficacy of the WFMA-based cortical interface

    From four-weeks post-op to end of device use, up to 3 years.

Study Arms (1)

WFMA Cortical Visual Prosthesis Single-arm Study

EXPERIMENTAL

The WFMA is an electronic device that is implanted in the cortical vision processing regions of the brain to produce artificial vision.

Device: WFMA - wireless floating microelectrode array

Interventions

WFMA - wireless floating microelectrode arrayDEVICE

Wirelessly transmitted patterns of electrical stimulation will be delivered to the visual cortex of study participants to generate visual percepts.

Also known as: ICVP System, ICVP, Intracortical Visual Prosthesis
WFMA Cortical Visual Prosthesis Single-arm Study

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No light perception or bare light perception, in each eye in accordance with relevant International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, where the physician has no expectation of improvement through currently approved treatments.
  • History of normal or near-normal vision, with or without refractive correction, during at least the first 10 years of life.
  • Adjusted to blindness for at least one year.
  • History of vision or blindness rehabilitation.
  • Willing and able to meet the time demands of the study with transportation assistance.
  • Willing to agree to audio and video recording, as specified in the pre-screening consent.
  • Motivated by altruism, willingness to participate in pioneering science.
  • Demonstrated support from spouse, family and/or friends.
  • High or average cognitive and spatial functioning.
  • Normal structural MRI.
  • English as preferred language.
  • Normal decision-making capacity.

You may not qualify if:

  • Poor adjustment to blindness, or vision loss within the last year.
  • Expectation of vision restoration to pre-blindness level through trial participation.
  • History of alcohol or drug dependence.
  • Evidence of prior immune response to an orthopedic implant which caused the implant to be explanted
  • A disease prognosis of living less than five years.
  • An implant which would prevent screening using MRI, or a pacemaker, or similar implant.
  • A history of seizures.
  • Current suicidal ideation.
  • Poor decision-making capacity.
  • Current diagnosis or history of severe mental illness.
  • Women who are pregnant or plan on becoming pregnant in the duration of the trial.
  • Hand Motion (HM) vision or better vision,
  • No Light Perception (NLP) or Light Perception (LP) vision with present OptoKinetic Nystagmus (OKN)
  • NLP vision with pupil constriction
  • Patients with Islands of perceivable vision in Goldmann Visual Field or Confrontational visual Field will also be excluded from the study.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illinois Institue of Technology

Chicago, Illinois, 60616, United States

RECRUITING

Related Publications (3)

  • Bak M, Girvin JP, Hambrecht FT, Kufta CV, Loeb GE, Schmidt EM. Visual sensations produced by intracortical microstimulation of the human occipital cortex. Med Biol Eng Comput. 1990 May;28(3):257-9. doi: 10.1007/BF02442682. No abstract available.

    PMID: 2377008BACKGROUND

  • Schmidt EM, Bak MJ, Hambrecht FT, Kufta CV, O'Rourke DK, Vallabhanath P. Feasibility of a visual prosthesis for the blind based on intracortical microstimulation of the visual cortex. Brain. 1996 Apr;119 ( Pt 2):507-22. doi: 10.1093/brain/119.2.507.

    PMID: 8800945BACKGROUND

  • Stephan K, Troyk PR, Dagnelie G, Cogan S, Barry MP, Grant P, Lane F, Szlyk JP, McNulty M, van Drongelen W, Pham TH, Stipp KL, Royster M, Towle VL. The Role of Scalp EEG Recordings During Cortical Visual Prosthesis Testing. Artif Organs. 2025 Sep;49(9):1417-1428. doi: 10.1111/aor.15023. Epub 2025 May 27.

    PMID: 40421717DERIVED

MeSH Terms

Conditions

Eye InjuriesOptic Nerve DiseasesBlindness

Condition Hierarchy (Ancestors)

Facial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesEye DiseasesWounds and InjuriesCranial Nerve DiseasesVision DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philip R Troyk, PhD

    Illinois Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Director

CONTACT

312-567-5304ICVP@iit.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Eligible participants for the study will be persons with blindness who meet the listed inclusion criteria. Individuals having any of the listed exclusion criteria will not be eligible to participate in the study. Enrolled participants will receive electrical stimulation devices implanted in the cortical region of their brain that is involved in vision processing. A maximum of five participants will be implanted. Written Informed Consent will be obtained from all participants before they are enrolled in the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

November 18, 2020

Study Start

August 20, 2020

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

We may electively share de-identified study data with collaborators

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Duration of the study
Access Criteria
Data required by study collaborators to perform analysis of safety and efficacy of the ICVP system.

Locations

US(1)