NCT03423654

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 18, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

January 23, 2018

Results QC Date

May 12, 2020

Last Update Submit

June 4, 2020

Conditions

Blind

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Training Group

EXPERIMENTAL

Spatial training

Other: Spatial Training

Control Group

OTHER

Letter number matching

Other: Letter number matching

Interventions

Spatial TrainingOTHER

Spatial Training using a 5x5 grid

Training Group
Letter number matchingOTHER

Letter number matching

Control Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University

Atlanta, Georgia, 30307, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Results Point of Contact

Title
April Maa
Organization
VA
april.maa2@va.gov
4043216111

Study Officials

  • April Y. Maa, MD BS

    Atlanta VA Medical and Rehab Center, Decatur, GA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Spatial Training group and Control group
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 6, 2018

Study Start

March 30, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

June 18, 2020

Results First Posted

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)