Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment

NCT05377853 | Unknown

• 1 other identifier: EY024056
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Blindness; Blindness, Acquired; Low Vision; Blindness, Complete

Keywords

blindness; plasticity; spatial memory; training; navigation

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Transfer of training to untrained spatio-cognitive abilities

  6-10 days

• Maintenance of transfer of training to untrained spatio-cognitive abilities

  3-6 months

• Change in Diffusion Tensor Imaging (DTI) in the cortical navigation network

  6-10 days

• Maintenance of change in Diffusion Tensor Imaging (DTI) in the cortical navigation network

  3-6 months

• Change in mobility self-assessment

  3-6 months

Other Outcomes (6)

• Age

  Pre-training timepoint

• Gender

  Pre-training timepoint.

• Current level of vision

  Pre-training timepoint

Study Arms (1)

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.

Behavioral: Cognitive-Kinesthetic Navigational Training

Interventions

Cognitive-Kinesthetic Navigational Training BEHAVIORAL

Training with tactile maps to improve spatial memory capability for enhanced navigational capabilities.

Blindness history

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Behavioral Studies:
• Neurological deficits
• Inability to normally control lower or upper extremities
• Inability to hear and understand instructions.
• Brain Imaging Studies:

Sponsors & Collaborators

• Smith-Kettlewell Eye Research Institute: lead

Study Sites (1)

Smith-Kettlewell Eye Research Institute

San Francisco, California, 94115, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 33223582 RESULT

• 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.

  PMID: 34566588 RESULT

• 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.

  PMID: 23346061 RESULT

• 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.

  PMID: 28890944 RESULT

• 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.

  PMID: 28347878 RESULT

• 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.

  PMID: 31633079 RESULT

• 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.

  PMID: 22593738 RESULT

MeSH Terms

Conditions

Blindness; Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lora T Likova

  Senior Scientist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lora T Likova

CONTACT

415 345 2066; lora@ski.org

Christopher W Tyler

CONTACT

415 345 2020; cwt@ski.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple regression analyses with life history and vision-related clinical factors as covariates

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 17, 2022
• Study Start: February 15, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

US (1)