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

NCT04276610 | Terminated

• 1 other identifier: CRIR-1284-1217
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Age-related Macular Degeneration; Dementia; Low Vision; Low Vision Aids; Hearing Loss; Reading Problem; Cognitive Impairment

Outcome Measures

Primary Outcomes (4)

• 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.

  15 minutes

• 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.

  2 minutes

• 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

  4 minutes

• 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.

  3 minutes

Secondary Outcomes (4)

• Minnesota Reading Test (MNRead)

  2 minutes

• Depression, Anxiety and Stress Scale

  5 minutes

• Canadian Digit Triplet Test

  4 minutes

• Magnetic Resonance Imaging (MRI) - for subset of participants

  45 minutes

Study Arms (3)

Healthy Control Participants

NO INTERVENTION

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

Low Vision Participants

EXPERIMENTAL

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.

Behavioral: Low Vision Reading Rehabilitation

Dual Sensory Impairment Participants

EXPERIMENTAL

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.

Behavioral: Low Vision Reading Rehabilitation

Interventions

Low Vision Reading Rehabilitation BEHAVIORAL

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.

Also known as: Use of magnification devices

Dual Sensory Impairment Participants; Low Vision Participants

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Complete blindness
• Inability to communicate verbally
• Inability to independently give informed written consent

Sponsors & Collaborators

• Université de Montréal: lead
• Fonds de la Recherche en Santé du Québec: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Institut Nazareth et Louis-Braille du CISSS de la Montérégie-Centre

Longueuil, Quebec, J4K 5G4, Canada

Location

Centre de réadaptation Lethbridge-Layton-Mackay du CIUSSS du Centre-Ouest-de-l'Île-de-Montréal

Montreal, Quebec, H4B 1R3, Canada

Location

Related Publications (2)

• 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.

  PMID: 33704074 BACKGROUND

• 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.

  PMID: 37034930 RESULT

Related Links

• Open-access link for protocol publication

MeSH Terms

Conditions

Macular Degeneration; Dementia; Vision, Low; Hearing Loss; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Cognition Disorders

Study Officials

• Walter Wittich, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 19, 2020
• Study Start: May 16, 2017
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)