search
Back to results

Words on the Brain: Can Reading Rehabilitation for Age-Related Vision Impairment Improve Cognitive Functioning? (WOTB)

Primary Purpose

Age-related Macular Degeneration, Dementia, Low Vision

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low Vision Reading Rehabilitation
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Able to communicate in either English or French
  2. Impairment of central vision, affecting acuity due to any diagnosis
  3. Visual acuity in the better eye with best standard correction of 20/60 or less
  4. Potential benefit from magnification or other reading rehabilitation interventions, as determined by rehabilitation professional.
  5. Client dossier with one of the partnering rehabilitation agencies.

Exclusion Criteria:

  1. Complete blindness
  2. Inability to communicate verbally
  3. Inability to independently give informed written consent

Sites / Locations

  • Institut Nazareth et Louis-Braille du CISSS de la Montérégie-Centre
  • Centre de réadaptation Lethbridge-Layton-Mackay du CIUSSS du Centre-Ouest-de-l'Île-de-Montréal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Healthy Control Participants

Low Vision Participants

Dual Sensory Impairment Participants

Arm Description

Older adults (65+) without impairments in vision or hearing. This groups will simply be followed for the study period (1 year), measured at 6 months intervals, to provide control comparison data for all outcome measures

Older adults (65+) with impairments in vision but without hearing impairment. This groups will receive regular standard of low vision rehabilitation care and will be followed for the study period (1 year), measured at 6 months intervals.

Older adults (65+) with impairments in both vision hearing hearing. This groups will receive regular standard of low vision rehabilitation care and will be followed for the study period (1 year), measured at 6 months intervals.

Outcomes

Primary Outcome Measures

Rey Auditory Verbal Learning Test (RAVLT)
Participants are verbally presented with a list of 15 words that they are asked to repeat and memorize, then recall immediately, and again recall them 15 minutes later. The score is the number of items recalled from 0 to 15, with higher scores indicating better recall.
Letter Number Sequencing task
Participants are asked to speak out loud the first 13 letters of the alphabet and alternate them with consecutive numbers (e.g., 1 - A - 2 - B 3 -C ...). The score is the number of correct alternations between numbers and letter, from 0 to 26, with higher scores indicating better performance.
Montreal Cognitive Assessment - full or blind version
Participants are asked to complete the visual and auditory items of this cognitive screening measure. The Blind versions (no visual items is utilized for persons whose vision is too impaired to see the pictograms). The score is the total number of items completed correctly, ranging from 0 to 30 for the full version, and 0 to 22 for the Blind version, with higher scores indicating better outcomes
1-n-back task
Participants are asked to verbally repeat a string of numbers presented orally, while naming the previous item to the one just presented. The score is the total number of correct recalls, ranging from 0 to 25, with higher scores indicating better performance.

Secondary Outcome Measures

Minnesota Reading Test (MNRead)
Participants are asked to read individual sentences on an eye chart. The log score indicates reading acuity ranging from -0.1 to 1.0 with higher numbers indicating poorer acuity.
Depression, Anxiety and Stress Scale
A 21-item questionnaire that measures the self-reported perception of depression, anxiety and stress on its three sub-scales, respectively. Scores for each item are from 0 to 3. Higher scores indicate higher levels of perceived depression, anxiety and stress, ranging each from 0 to 21 for each sub-scale.
Canadian Digit Triplet Test
A test measuring speech-in-noise perception. Participants are presented with three spoken digits through a head-set, and are asked to then enter them on a keyboard. Correct repetition will increase background noise, while incorrect answers will decrease background noise. The outcome measure is the estimated threshold for the signal-to-noise ratio where a participant can still comprehend the spoken digits. More negative score ratios indicate more tolerance to noise, therefore indicating better performance
Magnetic Resonance Imaging (MRI) - for subset of participants
Cortical invasive scan to measure structure and volume of brain regions involved in reading and sensory processing. Participants will placed in a Magnetic Resonance Imaging scanner in order to obtain structural measurement of their cortical architecture. Participants are asked to remain still a possible during these scans; however, they are not required to be otherwise engaged in any activity or decision-making. Higher volume measures indicate that more cortical volume is allocated to specific brain regions. This does not necessarily imply a functional judgment on its capacity, but is an anatomical measure only.

Full Information

First Posted
February 12, 2020
Last Updated
March 29, 2023
Sponsor
Université de Montréal
Collaborators
Fonds de la Recherche en Santé du Québec, Canadian Institutes of Health Research (CIHR)
search

1. Study Identification

Unique Protocol Identification Number
NCT04276610
Brief Title
Words on the Brain: Can Reading Rehabilitation for Age-Related Vision Impairment Improve Cognitive Functioning?
Acronym
WOTB
Official Title
Words on the Brain: Can Reading Rehabilitation for Age-Related Vision Impairment Improve Cognitive Functioning?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 has delayed the study recruitment beyond the available funding
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
Fonds de la Recherche en Santé du Québec, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Age-related vision impairment and dementia both become more prevalent with increasing age. Research into the mechanisms of these conditions has proposed that some of their causes (e.g., macular degeneration/glaucoma and Alzheimer's disease) could be symptoms of an underlying common cause, or may be equally linked to a multifactorial context in frailty and aging. Research into sensory-cognitive aging has provided preliminary data that sensory decline may be linked to the progression of dementia through the concept of sensory deprivation. Preliminary data in hearing loss rehabilitation support the idea that improved hearing may have a beneficial effect on cognitive functioning; however, there are to date no data available to examine whether low vision rehabilitation, specifically for reading, could have an equally protective or beneficial effect on cognitive health. The present proposal aims to fill this gap.
Detailed Description
The research questions are the following: Does low vision rehabilitation reduce reading effort? If so, does reduced reading effort increase reading activity, If so, does increased reading activity improve cognitive (memory) functioning? The objectives are to: Evaluate cognitive functioning and memory before, and 6 and 12 months after low vision reading rehabilitation using magnification in patients with age-related macular degeneration or glaucoma, compared to age-matched visually impaired controls who undergo rehabilitation that is NOT related to reading (e.g., mobility) Correlate participant characteristics with all cognitive outcome variables in order to identify potential mediators, moderators or confounders Hypotheses: Measures of reading (subjective and objective effort) will be statistically significantly reduced after participants have received strategies and tools to facilitate reading. Measures of reading behaviour will be negatively correlated with measures of reading effort (e.g., participants who report less effort will read more, more frequently and for longer) Individuals that demonstrate reduced reading effort/improved reading behaviour will demonstrate improved scores on cognitive tests after 6 months of having received rehabilitation strategies and tools, compared to those whose reading effort remains high or whose reading behaviour remains unchanged. These beneficial effects will be maintained after 12 months. Methodology Study Design: The study utilizes a quasi-experimental approach (nonrandomized, pre-post intervention study), an approach frequently used during the evaluation of health interventions. Specifically, a 2x3 design (2 groups x 3 time points) will allow for the examination of whether cognitive performance will change before and after 6 and 12 months of a low vision reading intervention, when comparing low vision patients to age-matched controls. Participants will also be audio-recorded throughout several of the tasks to not only ensure the highest level of precision when inputting and analyzing data, but will also help reduce the overall testing time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration, Dementia, Low Vision, Low Vision Aids, Hearing Loss, Reading Problem, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Control Participants
Arm Type
No Intervention
Arm Description
Older adults (65+) without impairments in vision or hearing. This groups will simply be followed for the study period (1 year), measured at 6 months intervals, to provide control comparison data for all outcome measures
Arm Title
Low Vision Participants
Arm Type
Experimental
Arm Description
Older adults (65+) with impairments in vision but without hearing impairment. This groups will receive regular standard of low vision rehabilitation care and will be followed for the study period (1 year), measured at 6 months intervals.
Arm Title
Dual Sensory Impairment Participants
Arm Type
Experimental
Arm Description
Older adults (65+) with impairments in both vision hearing hearing. This groups will receive regular standard of low vision rehabilitation care and will be followed for the study period (1 year), measured at 6 months intervals.
Intervention Type
Behavioral
Intervention Name(s)
Low Vision Reading Rehabilitation
Other Intervention Name(s)
Use of magnification devices
Intervention Description
Following Time 1, participants will receive the full complement of vision rehabilitation services available and deemed suitable by their clinical staff and rehabilitation professionals of either rehabilitation centre, according to the provision of assistive devices and services regulated by the Quebec Health Insurance (RAMQ). These services are include but are not limited to: a full optometric exam to determine functional vision, including refraction and the prescription of appropriate near and distance glasses and optical devices, an assessment by a low vision therapist and/or occupational therapist, the loan provision of hand-held optical magnification devices, electronic non-optical magnification devices (e.g., portable or table-top closed-circuit televisions), or computer software for screen content magnification (e.g., ZoomText), with appropriate training and follow-up sessions in the home, if required.
Primary Outcome Measure Information:
Title
Rey Auditory Verbal Learning Test (RAVLT)
Description
Participants are verbally presented with a list of 15 words that they are asked to repeat and memorize, then recall immediately, and again recall them 15 minutes later. The score is the number of items recalled from 0 to 15, with higher scores indicating better recall.
Time Frame
15 minutes
Title
Letter Number Sequencing task
Description
Participants are asked to speak out loud the first 13 letters of the alphabet and alternate them with consecutive numbers (e.g., 1 - A - 2 - B 3 -C ...). The score is the number of correct alternations between numbers and letter, from 0 to 26, with higher scores indicating better performance.
Time Frame
2 minutes
Title
Montreal Cognitive Assessment - full or blind version
Description
Participants are asked to complete the visual and auditory items of this cognitive screening measure. The Blind versions (no visual items is utilized for persons whose vision is too impaired to see the pictograms). The score is the total number of items completed correctly, ranging from 0 to 30 for the full version, and 0 to 22 for the Blind version, with higher scores indicating better outcomes
Time Frame
4 minutes
Title
1-n-back task
Description
Participants are asked to verbally repeat a string of numbers presented orally, while naming the previous item to the one just presented. The score is the total number of correct recalls, ranging from 0 to 25, with higher scores indicating better performance.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Minnesota Reading Test (MNRead)
Description
Participants are asked to read individual sentences on an eye chart. The log score indicates reading acuity ranging from -0.1 to 1.0 with higher numbers indicating poorer acuity.
Time Frame
2 minutes
Title
Depression, Anxiety and Stress Scale
Description
A 21-item questionnaire that measures the self-reported perception of depression, anxiety and stress on its three sub-scales, respectively. Scores for each item are from 0 to 3. Higher scores indicate higher levels of perceived depression, anxiety and stress, ranging each from 0 to 21 for each sub-scale.
Time Frame
5 minutes
Title
Canadian Digit Triplet Test
Description
A test measuring speech-in-noise perception. Participants are presented with three spoken digits through a head-set, and are asked to then enter them on a keyboard. Correct repetition will increase background noise, while incorrect answers will decrease background noise. The outcome measure is the estimated threshold for the signal-to-noise ratio where a participant can still comprehend the spoken digits. More negative score ratios indicate more tolerance to noise, therefore indicating better performance
Time Frame
4 minutes
Title
Magnetic Resonance Imaging (MRI) - for subset of participants
Description
Cortical invasive scan to measure structure and volume of brain regions involved in reading and sensory processing. Participants will placed in a Magnetic Resonance Imaging scanner in order to obtain structural measurement of their cortical architecture. Participants are asked to remain still a possible during these scans; however, they are not required to be otherwise engaged in any activity or decision-making. Higher volume measures indicate that more cortical volume is allocated to specific brain regions. This does not necessarily imply a functional judgment on its capacity, but is an anatomical measure only.
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to communicate in either English or French Impairment of central vision, affecting acuity due to any diagnosis Visual acuity in the better eye with best standard correction of 20/60 or less Potential benefit from magnification or other reading rehabilitation interventions, as determined by rehabilitation professional. Client dossier with one of the partnering rehabilitation agencies. Exclusion Criteria: Complete blindness Inability to communicate verbally Inability to independently give informed written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Wittich, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Nazareth et Louis-Braille du CISSS de la Montérégie-Centre
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4K 5G4
Country
Canada
Facility Name
Centre de réadaptation Lethbridge-Layton-Mackay du CIUSSS du Centre-Ouest-de-l'Île-de-Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4B 1R3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33704074
Citation
Wittich W, Pichora-Fuller MK, Johnson A, Joubert S, Kehayia E, Bachir V, Aubin G, Jaiswal A, Phillips N. Effect of Reading Rehabilitation for Age-Related Macular Degeneration on Cognitive Functioning: Protocol for a Nonrandomized Pre-Post Intervention Study. JMIR Res Protoc. 2021 Mar 11;10(3):e19931. doi: 10.2196/19931.
Results Reference
background
PubMed Identifier
37034930
Citation
Aubin G, Phillips N, Jaiswal A, Johnson AP, Joubert S, Bachir V, Kehayia E, Wittich W. Visual and cognitive functioning among older adults with low vision before vision rehabilitation: A pilot study. Front Psychol. 2023 Mar 22;14:1058951. doi: 10.3389/fpsyg.2023.1058951. eCollection 2023.
Results Reference
result
Links:
URL
https://www.researchprotocols.org/2021/3/e19931
Description
Open-access link for protocol publication

Learn more about this trial

Words on the Brain: Can Reading Rehabilitation for Age-Related Vision Impairment Improve Cognitive Functioning?

We'll reach out to this number within 24 hrs