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Spatial Cognitive Training

Spatial Cognitive Training in Visual Impairment

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03423654
Acronym
SCTVI
Enrollment
6
Registered
2018-02-06
Start date
2018-03-30
Completion date
2019-06-30
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blind

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.

Interventions

OTHERSpatial Training

Spatial Training using a 5x5 grid

OTHERLetter number matching

Letter number matching

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Spatial Training group and Control group

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Spatial Ability1 monthAbility 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Training Group
Spatial training Spatial Training: Spatial Training using a 5x5 grid
3
Control Group
Letter number matching Letter number matching: Letter number matching
3
Total6

Baseline characteristics

CharacteristicControl GroupTotalTraining Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants2 Participants1 Participants
Age, Categorical
Between 18 and 65 years
2 Participants4 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants3 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
2 Participants3 Participants1 Participants
Sex: Female, Male
Female
2 Participants4 Participants2 Participants
Sex: Female, Male
Male
1 Participants2 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 30 / 3
other
Total, other adverse events
0 / 30 / 3
serious
Total, serious adverse events
0 / 30 / 3

Outcome results

Primary

Spatial Ability

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.

Time frame: 1 month

Population: Study terminated early and not enough data collected to be able to run proper analysis. Some data lost due to machine malfunction. Statistics was not able to be performed due to lost data.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026