Blindness Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | February 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Smith-Kettlewell Eye Research Institute | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Smith-Kettlewell Eye Research Institute |
United States,
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. — View 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. — View 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.24 — View 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. — View 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 — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age | The covariate of age of the participants will be measured in years. | Pre-training timepoint | |
Other | Gender | The covariate of gender of the participants will be measured in three categorical values (male, intermediate, female). | Pre-training timepoint. | |
Other | 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. | Pre-training timepoint | |
Other | 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. | Pre-training timepoint | |
Other | Duration of full vision | The covariate of duration of full vision of the participants will be measured in years. | Pre-training timepoint | |
Other | Duration of Orientation and Mobility (O&M) training | The covariate of O&M training of the participants will be measured in years. | Pre-training timepoint | |
Primary | 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. |
6-10 days | |
Primary | 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. | 3-6 months | |
Primary | 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. | 6-10 days | |
Primary | 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. | 3-6 months | |
Primary | 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. | 6-10 days | |
Primary | 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. | 3-6 months | |
Primary | 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. | 6-10 days | |
Primary | 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. | 3-6 months | |
Primary | 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. | 6-10 days | |
Primary | 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. | 3-6 months | |
Primary | 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. | 6-10 days | |
Primary | 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. | 3-6 months | |
Primary | 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. | 6-10 days | |
Primary | 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. | 3-6 months | |
Secondary | 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. | 6-10 days | |
Secondary | 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. | 3-6 months | |
Secondary | 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. | 6-10 days | |
Secondary | 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. | 3-6 months | |
Secondary | 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. | 3-6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02393118 -
A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury
|
N/A | |
Terminated |
NCT00262509 -
Emergency Egress and Information System for Persons With Vision Loss
|
N/A | |
Terminated |
NCT00691444 -
Blind Child Melatonin Treatment Study
|
N/A | |
Recruiting |
NCT06237829 -
Testing Tactile Aids With Blind Subjects
|
N/A | |
Completed |
NCT00829036 -
Wayfinding Information Access System for People With Vision Loss
|
N/A | |
Completed |
NCT01488786 -
A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind
|
N/A | |
Completed |
NCT02643238 -
Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation
|
N/A | |
Recruiting |
NCT00403143 -
Do Blue-Blocking Lenses Block Blue Colour From Our Lives?
|
N/A | |
Recruiting |
NCT06451172 -
Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
|
Early Phase 1 | |
Recruiting |
NCT04725760 -
Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
|
N/A | |
Recruiting |
NCT02983370 -
Development of a Cortical Visual Neuroprosthesis for the Blind
|
N/A | |
Not yet recruiting |
NCT06070467 -
Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases
|
||
Completed |
NCT00920231 -
Computer Vision System for the Blind Veteran
|
Phase 1 | |
Completed |
NCT01109576 -
Workshops for Veterans With Vision and Hearing Loss
|
Phase 0 | |
Terminated |
NCT00795236 -
Melatonin Studies of Totally Blind Children
|
N/A | |
Terminated |
NCT00634972 -
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
|
Phase 4 | |
Enrolling by invitation |
NCT06364605 -
MySpace: the Role of Vision in Representing Space
|
N/A | |
Terminated |
NCT03913130 -
Extension Study to Study PQ-110-001 (NCT03140969)
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05806684 -
Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
|
||
Completed |
NCT03753893 -
Ocular Manifestations in Rheumatic Diseases
|