Sensory Substitution and Brain Plasticity Following Vision Loss (SenSubMRI)

Neurobehavioral Effects of Visual Assistive Technologies

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blindness
• Intervention / Treatment: Device: Vision-to-sound converter (AI Sight); Device: Electrotactile display (BrainPort); Device: Sham

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Team; Phone Number: 650-497-0625; Email: kevinchan@stanford.edu
• Study Contact Backup: Name: Mariana Nunez, CCRP; Phone Number: 650-497-7846; Email: mnunez1@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute at Stanford University
      • Contact: Study Team; Phone Number: (650) 497-0625; Email: kevinchan@stanford.edu
      • Contact: Mariana Nunez, CCRP; Phone Number: (650) 497-7846; Email: mnunez1@stanford.edu
    • Stanford, California, United States, 94305
      • LUCAS Center for Imaging
      • Contact: Study Team; Phone Number: (650) 512-7836; Email: lucascenter@stanford.edu
      • Contact: Karla Epperson, RT(MR)(ARMRIT); Email: karlae@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 8-85 years old for blind individuals; or 18-85 years old for sighted controls.
2. (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.
3. Able to hear the Informed Consent Form being read out to him or her, to understand it, and sign the Informed Consent Form.
4. Able to undergo functional neuroimaging tests.
5. Able to walk and stand independently.
6. Able to understand and remember the training protocols involved in the research study.
7. Willing and able to use the provided sensory substitution system to solve simple visual tasks.
8. Willing and able to complete simple tactile or auditory tasks.
9. Able to communicate by telephone and/or computer with research staff.

Exclusion Criteria:

1. Prior use with the sensory substitution device under investigation. This applies to both the auditory and tactile stimulators.
2. 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).
3. Pregnant or breastfeeding by self-report or urine test.
4. Is a prisoner or has any required movements legally restricted.
5. Unwilling or unable to adhere to all study requirements, including completion of the training period and any evaluation tests.
6. Implanted electrical medical devices such as pacemakers.
7. Claustrophobia that would prevent functional neuroimaging.
8. Obesity preventing placement in the MRI scanner.
9. 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).
10. Documented or suspected brain damage resulting in significant cognitive or sensory impairment (e.g., traumatic brain injury).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vision-to-sound sensory substitution training; Participants will learn to interpret the sound patterns that are converted from visual information while using the assistive technology.	Device: Vision-to-sound converter (AI Sight); The AI Sight is an auditory technology software that can convert visual information into sound patterns, which can be delivered through regular headphones.
Experimental: Vision-to-touch sensory substitution training; Participants will learn to interpret the touch patterns that are converted from visual information while using the assistive technology.	Device: Electrotactile display (BrainPort); 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.
Sham Comparator: Sham training; Participants will learn to interpret the sound/touch patterns verbally without presenting the sensory signals from the assistive technologies.	Device: Sham; Participants will wear the assistive technology system, but there will be no active sensory signals applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correct responses to visual performance tasks	Measuring the change in the number of correct responses to visual performance tasks from baseline to week 5.	5 weeks
Reaction time to visual performance tasks	Measuring the change in reaction time to visual performance tasks from baseline to week 5.	5 weeks
Metabolic brain profile	Measuring the change in neurometabolic markers by magnetic resonance spectroscopy from baseline to week 5.	5 weeks
Blood-oxygenation-level-dependent functional brain activity level	Measuring the change in blood-oxygenation-level-dependent brain activity level by T2*-weighted functional magnetic resonance imaging from baseline to week 5.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gray matter density	The change in gray matter density signals from T1-weighted magnetic resonance imaging through 5 weeks	5 weeks
White matter directional diffusivity	The change in directional diffusivity in the white matter microstructures measured from advanced diffusion magnetic resonance imaging through 5 weeks	5 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Kevin C. Chan, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Assistive technology; Magnetic resonance imaging; Brain; Blindness; Touch; Sensory substitution; Sound; Visual cortex
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Blindness
• Other Study ID Numbers: 80671; R01EY034897 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No