Experimental and Clinical Studies of Retinal Stimulation

NCT ID: NCT03635645

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2023-10-30

Brief Summary

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The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.

Detailed Description

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The study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.

Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Retinal stimulation

Alternative stimulus patterns will be tested (vs. baseline). The intervention is the alternative stimulus pattern. The intervention will be tested only in the clinic vs. baseline. The subject will go home with baseline settings. The two alternative stimulus patterns to be tested are asymmetric waveforms and bipolar stimulus.

Group Type EXPERIMENTAL

New visual processing unit (VPU) with asymmetric waveforms

Intervention Type DEVICE

A VPU will apply asymmetric and symmetric stimulation pulses.

New VPU with bipolar stimulation

Intervention Type DEVICE

A VPU will apply bipolar stimulus pulses.

Interventions

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New visual processing unit (VPU) with asymmetric waveforms

A VPU will apply asymmetric and symmetric stimulation pulses.

Intervention Type DEVICE

New VPU with bipolar stimulation

A VPU will apply bipolar stimulus pulses.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Must be implanted with an Argus II Retinal Prosthesis system.
* Have 5 or more electrodes that create a perception with stimulation.
* Must be willing and able to comply with the protocol testing requirements.

Exclusion Criteria

* Subjects participating in another investigatory drug or device study
* Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.
Minimum Eligible Age

25 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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James Weiland

Professor of Biomedical Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Weiland

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James Weiland

Role: CONTACT

Phone: 661-713-4603

Email: [email protected]

Facility Contacts

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James Weiland

Role: primary

Other Identifiers

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R01EY022931-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00122699

Identifier Type: -

Identifier Source: org_study_id