Not provided
Not provided
Not provided
Not provided
Study closed out due to recruitment complications.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training Group | Experimental | Spatial training |
|
| Control Group | Other | Letter number matching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spatial Training | Other | Spatial Training using a 5x5 grid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
Not provided
Not provided
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:
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:
Participants will also be excluded if MRI scanning is contra-indicated, e.g.:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| April Y. Maa, MD BS | Atlanta VA Medical and Rehab Center, Decatur, GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30307 | United States | ||
| Atlanta VA Medical and Rehab Center, Decatur, GA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Training Group | Spatial training Spatial Training: Spatial Training using a 5x5 grid |
| FG001 | Control Group | Letter number matching Letter number matching: Letter number matching |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Training Group | Spatial training Spatial Training: Spatial Training using a 5x5 grid |
| BG001 | Control Group | Letter number matching Letter number matching: Letter number matching |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 1 month |
|
Approximately 4 week per participant.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Training Group | Spatial training Spatial Training: Spatial Training using a 5x5 grid |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| April Maa | VA | 4043216111 | 206817 | april.maa2@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2018 | Apr 15, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2018 | Jun 4, 2020 | Prot_SAP_001.pdf |
Not provided
Spatial Training group and Control group
Not provided
Not provided
Not provided
Not provided
| Letter number matching |
| Other |
Letter number matching |
|
| Decatur |
| Georgia |
| 30033 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Control Group | Letter number matching Letter number matching: Letter number matching | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
Not provided