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NCT Number: NCT07450677

Sensory Substitution and Brain Plasticity Following Vision Loss

The goal of this clinical investigation is to learn how the brain responds when visual information is converted into patterns of sound or touch in blind and sighted participants. The main questions it aims to answer are:

* Does converting visual information into sound or touch patterns change visual performance in the blind or blindfolded? * How does the brain adapt to different kinds of sensory information?

Researchers will use brain imaging and simple performance tasks to see how people process and learn from this type of converted sensory input. The investigators will compare how individuals with and without long-term vision loss respond to these signals.

Participants will:

* Learn to use technologies to assist in visual information conversion into sound or touch patterns every day for 5 weeks; * Visit the brain imaging center 3 times for brain scans and behavioral tests.

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Key information

Age range

8 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute at Stanford University, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 8-85 years old for blind individuals; or 18-85 years old for sighted controls.
  • (a) Blind due to ocular impairment (documented visual acuity of light perception or worse) in both eyes, or (b) sighted healthy adult controls with corrected visual acuity of 20/40 or better and with no known vision disorders.
  • Able to hear the Informed Consent Form being read out to him or her, to understand it, and sign the Informed Consent Form.
  • Able to undergo functional neuroimaging tests.
  • Able to walk and stand independently.
  • Able to understand and remember the training protocols involved in the research study.
  • Willing and able to use the provided sensory substitution system to solve simple visual tasks.
  • Willing and able to complete simple tactile or auditory tasks.
  • Able to communicate by telephone and/or computer with research staff.

Exclusion criteria

  • Prior use with the sensory substitution device under investigation. This applies to both the auditory and tactile stimulators.
  • Presence of any foreign metal in the body, except for dental fillings (will need to be pre-screened by a radiologist prior to signing the informed consent and enrollment).
  • Pregnant or breastfeeding by self-report or urine test.
  • Is a prisoner or has any required movements legally restricted.
  • Unwilling or unable to adhere to all study requirements, including completion of the training period and any evaluation tests.
  • Implanted electrical medical devices such as pacemakers.
  • Claustrophobia that would prevent functional neuroimaging.
  • Obesity preventing placement in the MRI scanner.
  • No known neurological disorders or any medical condition that can possibly lead to emergency medical care (e.g., history of seizures, family history of epilepsy, stroke, severe headaches, use of medication for neurological or psychiatric conditions).
  • Documented or suspected brain damage resulting in significant cognitive or sensory impairment (e.g., traumatic brain injury).

Treatment and study plan

Electrotactile display (BrainPort)

Device

The BrainPort is a non-surgical assistive device that translates digital information from a video camera to gentle electrotactile stimulation patterns on the surface of the tongue.

Vision-to-sound converter (AI Sight)

Device

The AI Sight is an auditory technology software that can convert visual information into sound patterns, which can be delivered through regular headphones.

SHAM

Device

Participants will wear the assistive technology system, but there will be no active sensory signals applied.

Primary outcomes

  1. Number of correct responses to visual performance tasks

    Time frame: 5 weeks

    Measuring the change in the number of correct responses to visual performance tasks from baseline to week 5.

  2. Reaction time to visual performance tasks

    Time frame: 5 weeks

    Measuring the change in reaction time to visual performance tasks from baseline to week 5.

  3. Metabolic brain profile

    Time frame: 5 weeks

    Measuring the change in neurometabolic markers by magnetic resonance spectroscopy from baseline to week 5.

  4. Blood-oxygenation-level-dependent functional brain activity level

    Time frame: 5 weeks

    Measuring the change in blood-oxygenation-level-dependent brain activity level by T2*-weighted functional magnetic resonance imaging from baseline to week 5.

Secondary outcomes

  1. Gray matter density

    Time frame: 5 weeks

    The change in gray matter density signals from T1-weighted magnetic resonance imaging through 5 weeks

  2. White matter directional diffusivity

    Time frame: 5 weeks

    The change in directional diffusivity in the white matter microstructures measured from advanced diffusion magnetic resonance imaging through 5 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Mariana Nunez, CCRP

CONTACT

[email protected]

650-497-7846

Study Team

CONTACT

[email protected]

650-497-0625

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Neurobehavioral Effects of Visual Assistive Technologies

Acronym: SenSubMRI

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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