- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05377853
Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment
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
Status
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
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
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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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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:
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
Investigators
- Principal Investigator: Lora T Likova, Senior Scientist
Publications and helpful links
General Publications
- Likova LT, Cacciamani L. Transfer of Learning in People Who Are Blind: Enhancement of Spatial-Cognitive Abilities Through Drawing. J Vis Impair Blind. 2018 Jul 1;112(4):385-397. doi: 10.1177/0145482x1811200405.
- Likova LT, Mineff KN, Nicholas SC. Mental Visualization in the Cerebellum: Rapid Non-motor Learning at Sub-Lobular and Causal Network Levels. Front Syst Neurosci. 2021 Sep 10;15:655514. doi: 10.3389/fnsys.2021.655514. eCollection 2021.
- Likova LT. A Cross-Modal Perspective on the Relationships between Imagery and Working Memory. Front Psychol. 2013 Jan 18;3:561. doi: 10.3389/fpsyg.2012.00561. eCollection 2012.
- Likova LT, Tyler CW, Cacciamani L, Mineff K, Nicholas S. The Cortical Network for Braille Writing in the Blind. IS&T Int Symp Electron Imaging. 2016;2016:10.2352/ISSN.2470-1173.2016.16.HVEI-095. doi: 10.2352/ISSN.2470-1173.2016.16.HVEI-095. Epub 2016 Feb 14.
- Cacciamani L, Likova LT. Memory-guided drawing training increases Granger causal influences from the perirhinal cortex to V1 in the blind. Neurobiol Learn Mem. 2017 May;141:101-107. doi: 10.1016/j.nlm.2017.03.013. Epub 2017 Mar 24.
- Likova LT, Mei M, Mineff KN, Nicholas SC. Learning face perception without vision: Rebound learning effect and hemispheric differences in congenital vs late-onset blindness. IS&T Int Symp Electron Imaging. 2019 Jan 13;2019:2371-23713. doi: 10.2352/ISSN.2470-1173.2019.12.HVEI-237.
- Likova LT. Drawing enhances cross-modal memory plasticity in the human brain: a case study in a totally blind adult. Front Hum Neurosci. 2012 May 14;6:44. doi: 10.3389/fnhum.2012.00044. eCollection 2012.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EY024056
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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