UnknownNot Applicable

Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment

United States75 participantsStarted 2022-02-15

Plain-language summary

One of the most challenging tasks for blind and visually impaired individuals is navigation through a complex environment. The goal of the present multidisciplinary study is to increase spatial-cognition abilities in people who are blind or visually impaired through training with the previously-developed Cognitive-Kinesthetic Rehabilitation Training to improve navigation, and to investigate the resultant neuroplastic brain reorganization through multimodal brain imaging. In accordance with National Eye Institute (NEI) strategic goals, this multidisciplinary project will promote the development of well-informed new approaches to navigational rehabilitation, memory enhancement and cross-modal brain plasticity to benefit 'cutting edge' fields of mobile assistive technologies, vision restoration and memory facilitation for the aging brain.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Behavioral Studies: * Vision from \< 20/500 to NLP (No Light Perception) Brain Imaging Studies: * Vision from \< 20/500 to NLP * Within average gender range for height +/-1 standard deviation * Within average gender range for weight +/-1 standard deviation * Comfortable with MRI procedures Exclusion Criteria: Behavioral Studies: * Neurological deficits * Inability to normally control lower or upper extremities * Inability to hear and understand instructions. Brain Imaging Studies: * All standard MRI exclusion criteria, such as having any metallic objects in the body, or being too large to fit or operate comfortably in the scanner bore.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in blind map drawing speed from pre-training (Pre) to immediate post-training (Post1) timepoints

Timeframe: 6-10 days

Maintenance of change in blind map drawing speed from Post1 to extended post-training (Post2) timepoints

Timeframe: 3-6 months

Change in blind map drawing errors from Pre to Post1 timepoints

Timeframe: 6-10 days

Maintenance of change in blind map drawing errors from Post1 to Post2 timepoints

Timeframe: 3-6 months

Change in total navigation time during blind macro-scale navigation of the shortest path from Pre to Post1 timepoints

Timeframe: 6-10 days

Maintenance of change in number of total navigation time during blind navigation of the shortest path at macro-scale from Post1 to Post2 timepoints

Timeframe: 3-6 months

Change in total number of contact errors during blind macro-scale navigation from Pre to Post1 timepoints

Trial details

NCT IDNCT05377853

SponsorSmith-Kettlewell Eye Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02

Contact for this trial

Lora T Likova

415 345 2066 lora@ski.org

View on ClinicalTrials.gov More Blindness trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in blind map drawing speed from pre-training (Pre) to immediate post-training (Post1) timepoints

Timeframe: 6-10 days

Maintenance of change in blind map drawing speed from Post1 to extended post-training (Post2) timepoints

Timeframe: 3-6 months

Change in blind map drawing errors from Pre to Post1 timepoints

Timeframe: 6-10 days

Maintenance of change in blind map drawing errors from Post1 to Post2 timepoints

Timeframe: 3-6 months

Change in total navigation time during blind macro-scale navigation of the shortest path from Pre to Post1 timepoints

Timeframe: 6-10 days

Maintenance of change in number of total navigation time during blind navigation of the shortest path at macro-scale from Post1 to Post2 timepoints

Timeframe: 3-6 months

Change in total number of contact errors during blind macro-scale navigation from Pre to Post1 timepoints