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Clinical Trials/NCT03423654
NCT03423654
Terminated
Not Applicable

Spatial Cognitive Training in Visual Impairment

VA Office of Research and Development2 sites in 1 country6 target enrollmentMarch 30, 2018
ConditionsBlind

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blind
Sponsor
VA Office of Research and Development
Enrollment
6
Locations
2
Primary Endpoint
Spatial Ability
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

This study is designed to see if doing regular training on a spatial imagery task leads to improvements in the ability to do the trained spatial imagery task and in the ability to get around in everyday activities.

Detailed Description

The investigators will recruit 40 blind participants, randomized by the investigators' CVNR statistician into two groups. One group will undergo the experimental intervention (spatial cognitive training) and the other will undergo a control intervention involving letter-number matching. The participants will include women and minorities in proportion to the demographics of the Veteran population attending the Atlanta VA.

Registry
clinicaltrials.gov
Start Date
March 30, 2018
End Date
June 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Inability to perceive visual stimuli, i.e. no light perception, with stable visual loss over the past year
  • The investigators anticipate that causes of blindness will be ocular, including:
  • diabetic retinopathy and macular degeneration
  • the most common causes of blindness in Veterans
  • as well as possibly late-onset Leber's optic atrophy and ocular trauma (in the absence of TBI)
  • To minimize heterogeneity due to variations in age and the duration of visual loss, the investigators will restrict enrollment to Veterans and Non-Veterans over the age of 50 who lost light perception within the last 5 years, and who have completed standard O\&M training.
  • From a practical standpoint, this also enables the investigators to focus on participants who can potentially benefit most from the proposed intervention.

Exclusion Criteria

  • Participants will be excluded if they have any neurological condition, such as:
  • history of blast exposure
  • brain tumors
  • epilepsy, etc.
  • Participants will also be excluded if MRI scanning is contra-indicated, e.g.:
  • due to an implanted device such as a pacemaker
  • or foreign bodies of ferromagnetic nature
  • Cognitive screening will be performed using the Repeatable Battery for Assessment of Neuropsychological Status (RBANS, Randolph, 1998) and participants with cognitive impairment will be excluded based on a score of 1.5 SD below the mean for the Verbal Memory Index.
  • The investigators will test participants' hearing using a validated screening questionnaire (Screening Version of the Hearing Handicap Inventory for the Elderly, HHIE-S, Wentry \& Weinstein, 1983, Lichtenstein et al., 1988) followed by assessment of audiometric pure tone (0.5, 1.0, 2.0, 4.0 KHz) hearing thresholds in the CVNR sound booth.
  • Participants with more than mild hearing loss (HHIE score \>8 or audiometric thresholds \>40dB) will be excluded (Wentry \& Weinstein, 1983; Wilson, 2009), given that the investigators are relying on audio cues.

Outcomes

Primary Outcomes

Spatial Ability

Time Frame: 1 month

Ability to orient to where participants began at the beginning of task. Using a 5x5 grid on testing device, a 5x5 grid that the participant will have to walk, and a 5x5 grid during task in MRI.

Study Sites (2)

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