Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment

November 20, 2023 updated by: Smith-Kettlewell Eye Research Institute

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.

Study Overview

Detailed Description

The investigators propose a radical new multidisciplinary approach to navigation training in blindness and visual impairment. Successful navigation requires the development of an accurate and flexible mental, or cognitive, map of the navigational space and of the route trajectory required to travel from the current to the target location. The Cognitive-Kinesthetic (C-K) Rehabilitation Training that the PI has developed in the preceding period utilizes a unique form of blind memory-guided drawing to develop cognitive mapping to a high level of proficiency. Particular reliance must be placed on such mental maps (supported only by tactile and auditory inputs), and on the ability to use them effectively for spatiomotor control, when vision with its built-in spatial functionality is lost. There is, however, a fundamental gap in the practice of Orientation and Mobility (O&M), which is the lack of a specific emphasis on enhancement of these cognitive roots of spatiomotor activity, despite their known importance for navigation in the visually impaired.

The investigators therefore propose a rigorous multidisciplinary approach to this issue, which lies at the intersection of the fields of spatiomotor rehabilitation, blindness assessment technologies, and brain function, each a focus of one Specific Aim. To train the spatial cognition abilities underlying successful navigation, the current proposal aims to translate the power of the C-K Rehabilitation Training to the domain of navigation. The blind and visually impaired trainees will quickly learn how to generate precise and stable cognitive maps of haptically explored raised-line images or tactile maps, and how to use the formed cognitive maps to confidently guide both drawing 'hand navigation' on a map-scale, and whole-body blind navigation on the macro-scale. Once translated to navigation, the preliminary data show that this efficient and enjoyable training will rapidly and sustainably enhance spatial cognition functions both for improved navigation performance and for enhancement of more general spatial cognitive skills. Beyond its practical advantages, the rapid and effective training protocol will also serve as an efficient tool to drive and study training-based neuroplasticity mechanisms through a comprehensive whole-brain multimodal brain imaging platform.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lora T Likova
  • Phone Number: 415 345 2066
  • Email: lora@ski.org

Study Contact Backup

  • Name: Christopher W Tyler
  • Phone Number: 415 345 2020
  • Email: cwt@ski.org

Study Locations

    • California
      • San Francisco, California, United States, 94115
        • Recruiting
        • Smith-Kettlewell Eye Research Institute
        • Contact:
          • Lora T Likova, PhD
          • Phone Number: 415-345-2066
          • Email: lora@ski.org
        • Contact:
          • Christopher W Tyler, PhD
          • Phone Number: 415 345 2020
          • Email: cwt@ski.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blindness history
Since this is a regression analysis, all participants are assigned to the same Arm with blindness history and the demographics as covariates.
Training with tactile maps to improve spatial memory capability for enhanced navigational capabilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blind map drawing speed from pre-training (Pre) to immediate post-training (Post1) timepoints
Time Frame: 6-10 days

The trajectory of the drawing hand while performing memory-guided navigational tasks will be electronically recorded for assessment of from Pre to Post1 change in terms of drawing speed in cm/s.

Note: The three timepoints of the study are:

  • Pre: Immediately before the 5-day Cognitive-Kinesthetic training period
  • Post1: Immediately after the 5-day Cognitive-Kinesthetic training period
  • Post2: Within 3-6 months after Post1, without any training intervening between Post1 and Post2

The time frames for changes and maintenance assessment are given as ranges to allow for scheduling logistics but represent a single interval per participant for each measure.

6-10 days
Maintenance of change in blind map drawing speed from Post1 to extended post-training (Post2) timepoints
Time Frame: 3-6 months
The trajectory of the drawing hand while performing memory-guided navigational tasks will be assessed for Post1 to Post2 change in drawing speed in cm/s.
3-6 months
Change in blind map drawing errors from Pre to Post1 timepoints
Time Frame: 6-10 days
The trajectory of the drawing hand while performing memory-guided navigational tasks will be assessed for Pre to Post1 change in navigation drawing errors in terms of number of incorrect turns.
6-10 days
Maintenance of change in blind map drawing errors from Post1 to Post2 timepoints
Time Frame: 3-6 months
The trajectory of the drawing hand while performing memory-guided navigational tasks will be assessed for Post1 to Post2 change in navigation drawing errors in terms of number of incorrect turns.
3-6 months
Change in total navigation time during blind macro-scale navigation of the shortest path from Pre to Post1 timepoints
Time Frame: 6-10 days
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Pre to Post1 change in total navigation time in s.
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
Time Frame: 3-6 months
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Post1 to Post2 change in terms of total navigation time measured in s.
3-6 months
Change in total number of contact errors during blind macro-scale navigation from Pre to Post1 timepoints
Time Frame: 6-10 days
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Pre to Post1 change in terms of total number of contact errors.
6-10 days
Maintenance of change in total number of contact errors during blind macro-scale navigation from Post1 to Post2 timepoints
Time Frame: 3-6 months
A tactile map of the virtual layout will be explored and memorized; then, using the formed memory representation of the map, the participants will mentally plan the shortest route between two verbally-provided points on a street map, and walk along that route in the iPhone-encoded Virtual Environment within an Empty Real Space (iVEERS) system developed for this proposal. The iVEERS recorded shortest-path navigation trajectories will be assessed for Post1 to Post2 change in number of contact errors.
3-6 months
Change in functional MRI (fMRI) activation in the cortical navigation network
Time Frame: 6-10 days
Whole-brain fMRI will be run to measure activation in the cortical navigation network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The change in average activation in the cortical navigation network will be assessed from the Pre to Post1 timepoints in z-score units.
6-10 days
Maintenance of change in fMRI activation in the cortical navigation network
Time Frame: 3-6 months
Whole-brain fMRI will be run to measure activation in the cortical navigation network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The maintenance in average activation in the cortical navigation network will be assessed from the Post1 to Post2 timepoints in z-score units.
3-6 months
Change in functional MRI (fMRI) activation in the spatial working memory network
Time Frame: 6-10 days
Whole-brain fMRI will be run to measure activation in the spatial working memory network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The change in average activation in the spatial working memory network will be assessed from the Pre to Post1 timepoints in z-score units.
6-10 days
Maintenance of change in fMRI activation in the spatial working memory network
Time Frame: 3-6 months
Whole-brain fMRI will be run to measure activation in the spatial working memory network while the participant plans the shortest paths between two locations based on their memory representations of explored raised-line tactile maps. The change in average activation in the spatial working memory network will be assessed from the Post1 to Post2 timepoints in z-score units.
3-6 months
Change in Granger causal connectivity (GCC) density in the cortical navigation network
Time Frame: 6-10 days
The changes of the GC connectivity density in the navigation network from the Pre to Post1 will be assessed in terms of the connectivity density index, defined as the ratio of the number of significant GC connections to the number of network nodes.
6-10 days
Maintenance of change in GCC density in the cortical navigation network
Time Frame: 3-6 months
The changes of the GC connectivity density in the navigation network from the Post1 to Post2 will be assessed in terms of the connectivity density index, defined as the ratio of the number of significant GC connections to the number of network nodes.
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfer of training to untrained spatio-cognitive abilities
Time Frame: 6-10 days
The transfer of the training effect to untrained spatio-cognitive abilities will be assessed for a Pre to Post1 change in terms of the score on the Cognitive Test for the Blind (CTB) of the McCarron-Dial Comprehensive Vocational Evaluation System in its standardized IQ-style units.
6-10 days
Maintenance of transfer of training to untrained spatio-cognitive abilities
Time Frame: 3-6 months
The maintenance of the training effect to untrained spatio-cognitive abilities will be assessed for a Post1 to Post2 change on the Cognitive Test for the Blind (CTB) of the McCarron-Dial Comprehensive Vocational Evaluation System measured in its standardized IQ-style units.
3-6 months
Change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
Time Frame: 6-10 days
DTI will be used to assess the change in average voxelwise Fractional Anisotropy (FA) throughout the pathways of the cortical navigation network from the Pre to Post1 timepoints in FA z-score units.
6-10 days
Maintenance of change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
Time Frame: 3-6 months
DTI will be used to assess the change in average voxelwise FA throughout the pathways of the cortical navigation network from the Post1 to Post2 timepoints in FA z-score units.
3-6 months
Change in mobility self-assessment
Time Frame: 3-6 months
The Kuyk Mobility Function Questionnaire for blindness and profound visual impairment will be used to assess the change in effects of training on everyday mobility from the Pre to the Post2 timepoints in terms of its standardized score.
3-6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Pre-training timepoint
The covariate of age of the participants will be measured in years.
Pre-training timepoint
Gender
Time Frame: Pre-training timepoint.
The covariate of gender of the participants will be measured in three categorical values (male, intermediate, female).
Pre-training timepoint.
Current level of vision
Time Frame: Pre-training timepoint
The covariate of current level of vision of the participants will be measured with the Bailey-Lovey eyechart in Snellen units.
Pre-training timepoint
Age of onset of current level of vision
Time Frame: Pre-training timepoint
The covariate of age of onset of the current level of vision across of the participant will be measured in years.
Pre-training timepoint
Duration of full vision
Time Frame: Pre-training timepoint
The covariate of duration of full vision of the participants will be measured in years.
Pre-training timepoint
Duration of Orientation and Mobility (O&M) training
Time Frame: Pre-training timepoint
The covariate of O&M training of the participants will be measured in years.
Pre-training timepoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lora T Likova, Senior Scientist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blindness

Clinical Trials on Cognitive-Kinesthetic Navigational Training

Subscribe