Health TrialsbyHealthPanel

Sensory Substitution and Brain Plasticity Following Vision Loss

ConditionBlindness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-85
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Vision-to-sound sensory substitution trainingExperimental treatment 1 intervention
Group B: Vision-to-touch sensory substitution trainingExperimental treatment 1 intervention
Group C: Sham trainingSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 weeks
2

Reaction time to visual performance tasks

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

Time frame
5 weeks
3

Metabolic brain profile

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

Time frame
5 weeks
4

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.

Time frame
5 weeks

Secondary outcomes

1

Gray matter density

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

Time frame
5 weeks
2

White matter directional diffusivity

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

Time frame
5 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Eye Institute (NEI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: