Spatial Cognitive Training

NCT ID: NCT03423654

Last Updated: 2020-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Blind

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Spatial Training group and Control group
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Training Group

Spatial training

Group Type EXPERIMENTAL

Spatial Training

Intervention Type OTHER

Spatial Training using a 5x5 grid

Control Group

Letter number matching

Group Type OTHER

Letter number matching

Intervention Type OTHER

Letter number matching

Interventions

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Spatial Training

Spatial Training using a 5x5 grid

Intervention Type OTHER

Letter number matching

Letter number matching

Intervention Type OTHER

Eligibility Criteria

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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:

* glaucoma
* 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:

* TBI
* history of blast exposure
* stroke
* 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.
* The investigators will also exclude visually impaired Veterans who are dependent on a wheelchair or scooter for mobility, as they will not be able to take part in the real-world task.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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April Y. Maa, MD BS

Role: PRINCIPAL_INVESTIGATOR

Atlanta VA Medical and Rehab Center, Decatur, GA

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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C2243-P

Identifier Type: -

Identifier Source: org_study_id

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