BlindSCTVINCT03423654
Spatial Cognitive Training
A study testing Spatial Training and Letter number matching in people with Blind, run by VA Office of Research and Development at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Blind
- What is being tested?
- Spatial Training and Letter number matching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Mar 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants will be excluded if they have any neurological condition, such as:
- TBI
- history of blast exposure
- stroke
- brain tumors
- epilepsy, etc.
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30307
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
About this study
Official title: Spatial Cognitive Training in Visual Impairment
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.
Read the 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.
- Conditions
- Blind
- Being tested
- Spatial Training, Letter number matching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial TrainingOther
Spatial Training using a 5x5 grid
Letter number matchingOther
Letter number matching
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Spatial training Receives: Other: Spatial Training |
| Control Group | Other | Letter number matching Receives: Other: Letter number matching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start30 Mar 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: Study closed out due to recruitment complications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BlindStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Spatial Training group and Control group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- April Y. Maa, MD BS, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423654
- Sponsor's protocol ID
- C2243-P
- Acronym
- SCTVI
- Status last verified
- Jun 2020
- First submitted
- 23 Jan 2018
- Last updated
- 18 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Cognitive Training in Visual Impairment
- ClinicalTrials.gov ID
- NCT03423654
- Acronym / sponsor ID
- SCTVI / C2243-P
- Conditions
- Blind
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed out due to recruitment complications.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Posted 18 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Spatial Training group and Control group
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Spatial TrainingSpatial training |
| Control Group | Other | Other: Letter number matchingLetter number matching |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatial TrainingSpatial Training using a 5x5 grid | Other | Training Group |
| Letter number matchingLetter number matching | Other | Control Group |
Primary outcome
Spatial Ability
Time frame: 1 month
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April Y. Maa, MD BS principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatial Training and Letter number matching in people with Blind, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial Ability (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.