Clinical trial NCT05377853: Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment
Official title: Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blindness
Blindness, Acquired
Low Vision
Blindness, Complete
Keywords: blindness
plasticity
spatial memory
training
navigation
Lead sponsor: Smith-Kettlewell Eye Research Institute
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multiple regression analyses with life history and vision-related clinical factors as covariates
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in blind map drawing speed from pre-training (Pre) to immediate post-training (Post1) timepoints
timeFrame: 6-10 days
measure: Maintenance of change in blind map drawing speed from Post1 to extended post-training (Post2) timepoints
timeFrame: 3-6 months
measure: Change in blind map drawing errors from Pre to Post1 timepoints
timeFrame: 6-10 days
measure: Maintenance of change in blind map drawing errors from Post1 to Post2 timepoints
timeFrame: 3-6 months
measure: Change in total navigation time during blind macro-scale navigation of the shortest path from Pre to Post1 timepoints
timeFrame: 6-10 days
measure: 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
measure: Change in total number of contact errors during blind macro-scale navigation from Pre to Post1 timepoints
timeFrame: 6-10 days
measure: Maintenance of change in total number of contact errors during blind macro-scale navigation from Post1 to Post2 timepoints
timeFrame: 3-6 months
measure: Change in functional MRI (fMRI) activation in the cortical navigation network
timeFrame: 6-10 days
measure: Maintenance of change in fMRI activation in the cortical navigation network
timeFrame: 3-6 months
measure: Change in functional MRI (fMRI) activation in the spatial working memory network
timeFrame: 6-10 days
measure: Maintenance of change in fMRI activation in the spatial working memory network
timeFrame: 3-6 months
measure: Change in Granger causal connectivity (GCC) density in the cortical navigation network
timeFrame: 6-10 days
measure: Maintenance of change in GCC density in the cortical navigation network
timeFrame: 3-6 months
Secondary outcomes:
measure: Transfer of training to untrained spatio-cognitive abilities
timeFrame: 6-10 days
measure: Maintenance of transfer of training to untrained spatio-cognitive abilities
timeFrame: 3-6 months
measure: Change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
timeFrame: 6-10 days
measure: Maintenance of change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
timeFrame: 3-6 months
measure: Change in mobility self-assessment
timeFrame: 3-6 months
Other outcomes:
measure: Age
timeFrame: Pre-training timepoint
measure: Gender
timeFrame: Pre-training timepoint.
measure: Current level of vision
timeFrame: Pre-training timepoint
measure: Age of onset of current level of vision
timeFrame: Pre-training timepoint
measure: Duration of full vision
timeFrame: Pre-training timepoint
measure: Duration of Orientation and Mobility (O&M) training
timeFrame: Pre-training timepoint
Locations:
city: San Francisco
country: United States
facility: Smith-Kettlewell Eye Research Institute
state: California
Study officials:
affiliation: Senior Scientist
name: Lora T Likova
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.