ReadMap: Reading in Stroke Alexia and Typical Aging (ReadMap)

Loss of reading ability due to stroke, called alexia, likely affects over a million Americans at any given time and causes difficulty performing many daily life functions, such as paying bills, using email/text, reading for pleasure, and reading signs in the community. Understanding the brain and cognitive basis of alexia could improve diagnosis and treatment of this important problem. In this study, the investigators will perform a large-scale behavioral and brain imaging study of stroke survivors and typical older adults to improve our understanding of the brain and cognitive basis of reading in both of these groups.

Participants will complete a battery of tests of reading, speech, language, and thinking abilities. In addition, some participants will complete an MRI. Sessions will be completed across approximately 2-6 weeks, but may be extended depending on participants' schedules and availability. Some participants will be invited to repeat these procedures once or twice in approximately 3-12 months to monitor for changes in reading abilities and MRI measurements over time.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Aphasia; Alexia

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Alycia Laks, MS, CCC-SLP; Phone Number: 202-687-5205; Email: crlab@georgetown.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Recruiting
      • Georgetown University Medical Center
      • Contact: Alycia Laks, MS, CCC-SLP; Phone Number: 202-687-5205; Email: crlab@georgetown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants are survivors of left hemisphere stroke with or without reading difficulties, or people with aphasia or alexia due to strokes in other parts of the brain. The investigators recruit participants primarily from the Washington, DC region, but some participants may travel from farther away to participate in the study. The investigators aim for our participants to be fully representative of the diversity of individuals with stroke in the general population.

Control participants have not had a stroke or other brain injury, and are matched to stroke survivors on age, gender, race, educational background, and stroke risk factors.

Description

Inclusion criteria:

Stroke Survivors:

• Age >= 18
• Learned English at 8 years or younger
• Brain injury resulting from stroke

Controls:

• Age >= 18
• Learned English at 8 years or younger

Exclusion criteria for all groups:

• History of other brain disorder that could interfere with our ability to interpret results (e.g., Multiple sclerosis, dementia, head injury causing loss of consciousness)
• Severe psychiatric condition that would interfere with participation in the study
• History of diagnosed learning disorder
• Hearing or vision loss that interferes with performance on behavioral tests even after correction with glasses/hearing aids.
• Inability to follow study procedures despite maximal support

Additional exclusion criteria for MRIs:

• Presence of metal in the body that is incompatible with MRI
• Pregnancy
• Claustrophobia

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Stroke Survivors; Participants have had a left-hemisphere stroke, or a stroke elsewhere in the brain causing aphasia or alexia (i.e., reading difficulties). They are given a series of standardized and in-house tests of reading, language and cognition to provide a detailed profile of strengths and weaknesses, plus an MRI.
Controls; Participants are matched to the stroke cohort in age, educational background, race, and gender but have no history of brain injury. They are also given a series of standardized and in-house tests of reading, language and cognition to provide a detailed profile of strengths and weaknesses, plus an MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)	Part of MRI sequence that measures deep grey matter structure.	Collected within 1 month of behavioral testing
DTI (Diffusion Tensor Imaging)	Part of MRI sequence that measures the rate of water diffusion between cells to understand and create a map of internal structures.	Collected within 1 month of behavioral testing
Behavioral testing	Battery of standard clinical and in-house behavioral tests to measure speech, language, and cognition. Final score is derived from principle components analysis.	Collected within 1 month of MRI

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD); MedStar National Rehabilitation Network
• Investigators: Principal Investigator: Peter Turkeltaub, MD,PhD, Georgetown University; MedStar National Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: stroke; language; brain injury; apraxia; speech; aphasia; reading; alexia
• Additional Relevant MeSH Terms: Specific Learning Disorder; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Language Disorders; Learning Disabilities; Speech Disorders; Stroke; Aphasia; Dyslexia
• Other Study ID Numbers: ReadMap; R01DC020446 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No