Spatial Cognitive Training

Blind Clinical Trial

— SCTVI  

Official title:

Spatial Cognitive Training in Visual Impairment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03423654
• Other study ID #: C2243-P
• Status: Terminated
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blind

Intervention

Other:
• Spatial Training
Spatial Training using a 5x5 grid
• Letter number matching
Letter number matching

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 month