An interventional study of Cognitive-Kinesthetic Navigational Training in Blindness, Blindness, Acquired and Low Vision, sponsored by Smith-Kettlewell Eye Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Smith-Kettlewell Eye Research Institute · Not applicable, Interventional, and Treatment
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.
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.
144 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's planned enrollment of 75 is above the median of 37 across 101 interventional studies indexed under Blindness.
Browse Blindness studies →Smith-Kettlewell Eye Research Institute is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Behavioral Studies:
Brain Imaging Studies:
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Behavioral Studies:
Brain Imaging Studies:
Since this is a regression analysis, all participants are assigned to the same Arm with blindness history and the demographics as covariates.
Behavioral: Cognitive-Kinesthetic Navigational Training
Training with tactile maps to improve spatial memory capability for enhanced navigational capabilities.
Change in blind map drawing speed from pre-training (Pre) to immediate post-training (Post1) timepoints
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.
Time frame: 6-10 days
Maintenance of change in blind map drawing speed from Post1 to extended post-training (Post2) timepoints
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.
Time frame: 3-6 months
Change in blind map drawing errors from Pre to Post1 timepoints
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.
Time frame: 6-10 days
Maintenance of change in blind map drawing errors from Post1 to Post2 timepoints
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.
Time frame: 3-6 months
Change in total navigation time during blind macro-scale navigation of the shortest path from Pre to Post1 timepoints
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.
Time frame: 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
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.
Time frame: 3-6 months
Change in total number of contact errors during blind macro-scale navigation from Pre to Post1 timepoints
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.
Time frame: 6-10 days
Maintenance of change in total number of contact errors during blind macro-scale navigation from Post1 to Post2 timepoints
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.
Time frame: 3-6 months
Change in functional MRI (fMRI) activation in the cortical navigation network
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.
Time frame: 6-10 days
Maintenance of change in fMRI activation in the cortical navigation network
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.
Time frame: 3-6 months
Change in functional MRI (fMRI) activation in the spatial working memory network
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.
Time frame: 6-10 days
Maintenance of change in fMRI activation in the spatial working memory network
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.
Time frame: 3-6 months
Change in Granger causal connectivity (GCC) density in the cortical navigation network
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.
Time frame: 6-10 days
Maintenance of change in GCC density in the cortical navigation network
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.
Time frame: 3-6 months
Transfer of training to untrained spatio-cognitive abilities
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.
Time frame: 6-10 days
Maintenance of transfer of training to untrained spatio-cognitive abilities
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.
Time frame: 3-6 months
Change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
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.
Time frame: 6-10 days
Maintenance of change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
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.
Time frame: 3-6 months
Change in mobility self-assessment
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.
Time frame: 3-6 months
Age
The covariate of age of the participants will be measured in years.
Time frame: Pre-training timepoint
Gender
The covariate of gender of the participants will be measured in three categorical values (male, intermediate, female).
Time frame: Pre-training timepoint.
Current level of vision
The covariate of current level of vision of the participants will be measured with the Bailey-Lovey eyechart in Snellen units.
Time frame: Pre-training timepoint
Age of onset of current level of vision
The covariate of age of onset of the current level of vision across of the participant will be measured in years.
Time frame: Pre-training timepoint
Duration of full vision
The covariate of duration of full vision of the participants will be measured in years.
Time frame: Pre-training timepoint
Duration of Orientation and Mobility (O&M) training
The covariate of O\&M training of the participants will be measured in years.
Time frame: Pre-training timepoint
Started Feb 2022 (actual). Primary completion is estimated for Feb 2024, 24 months after the start.
Of 36 interventional studies with no phase under Blindness, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 19. This study's planned 24 months is below that.
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