BlindnessNCT05377853
Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment
A study testing Cognitive-Kinesthetic Navigational Training in people with Blindness and Blindness, Acquired, run by Smith-Kettlewell Eye Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blindness, Blindness, Acquired, Low Vision
- What is being tested?
- Cognitive-Kinesthetic Navigational Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Smith-Kettlewell Eye Research Institute
San Francisco, California, 94115
Lora T Likova, PhD, 415-345-2066, lora@ski.org
Christopher W Tyler, PhD, 415 345 2020, cwt@ski.org
About this study
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.
Read the 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.
- Conditions
- Blindness, Blindness, Acquired, Low Vision, Blindness, Complete
- Being tested
- Cognitive-Kinesthetic Navigational Training
- Keywords
- blindness, plasticity, spatial memory, training, navigation
- Medical subject headings
- Blindness, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Kinesthetic Navigational TrainingBehavioural
Training with tactile maps to improve spatial memory capability for enhanced navigational capabilities.
| Study group | Role | What they receive |
|---|---|---|
| Blindness history | Experimental | Since this is a regression analysis, all participants are assigned to the same Arm with blindness history and the demographics as covariates. Receives: Behavioral: Cognitive-Kinesthetic Navigational Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start15 Feb 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BlindnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple regression analyses with life history and vision-related clinical factors as covariates
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smith-Kettlewell Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lora T Likova, Principal investigator, Senior Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377853
- Sponsor's protocol ID
- EY024056
- Status last verified
- Nov 2023
- First submitted
- 6 May 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33223582Likova 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.
PubMed 34566588Likova 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.
PubMed 23346061Likova 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.
PubMed 28890944Cacciamani 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.
PubMed 28347878Likova 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.
PubMed 31633079Likova 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.
PubMed 22593738
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment
- ClinicalTrials.gov ID
- NCT05377853
- Acronym / sponsor ID
- EY024056
- Conditions
- Blindness, Blindness, Acquired, Low Vision, Blindness, Complete
- Keywords
- blindness, plasticity, spatial memory, training, navigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Smith-Kettlewell Eye Research InstituteUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple regression analyses with life history and vision-related clinical factors as covariates
| Arm | Type | Receives |
|---|---|---|
| Blindness history | Experimental | Behavioral: Cognitive-Kinesthetic Navigational TrainingSince this is a regression analysis, all participants are assigned to the same Arm with blindness history and the demographics as covariates. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Vision from < 20/500 to NLP (No Light Perception)
- 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
Key exclusion criteria (6 listed)
- Neurological deficits
- Inability to normally control lower or upper extremities
- Inability to hear and understand instructions.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Kinesthetic Navigational TrainingTraining with tactile maps to improve spatial memory capability for enhanced navigational capabilities. | Behavioural | Blindness history |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Transfer of training to untrained spatio-cognitive abilities
Time frame: 6-10 days
Maintenance of transfer of training to untrained spatio-cognitive abilities
Time frame: 3-6 months
Change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
Time frame: 6-10 days
Maintenance of change in Diffusion Tensor Imaging (DTI) in the cortical navigation network
Time frame: 3-6 months
Change in mobility self-assessment
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Results publication: PubMed 33223582Likova 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.
- Results publication: PubMed 34566588Likova 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.
- Results publication: PubMed 23346061Likova 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.
- Results publication: PubMed 28890944Likova 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.
- Results publication: PubMed 28347878Cacciamani 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.
- Results publication: PubMed 31633079Likova 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.
- Results publication: PubMed 22593738Likova 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.
Related trials for Blindness
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Not yet recruiting
Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Not yet recruiting
Remapping Text in Sentence and Word Tasks to Aid Reading With Central Vision Loss
Macular Degeneration, Central Visual Impairment
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lora T Likova principal investigator
Senior Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Kinesthetic Navigational Training in people with Blindness and Blindness, Acquired, run by Smith-Kettlewell Eye Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lora T Likova (415 345 2066, lora@ski.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blind map drawing speed from pre-training (Pre) to immediate post-training (Post1) timepoints (time frame: 6-10 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05377853, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.