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RecruitingNCT06700005ReadMapUpdated Nov 21, 2024

ReadMap: Reading in Stroke Alexia and Typical Aging

An observational study in Aphasia, Stroke and Alexia, sponsored by Georgetown University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Georgetown University · Observational

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Aphasia
  • Stroke
  • Alexia

Keywords

  • aphasia
  • stroke
  • brain injury
  • speech
  • language
  • reading
  • alexia
  • apraxia
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In context

Aphasia

338 studies on the registry are indexed under Aphasia; 95 are open to participants now.

This study's planned enrollment of 300 is above the median of 77 across 36 observational studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)

    Part of MRI sequence that measures deep grey matter structure.

    Time frame: Collected within 1 month of behavioral testing

  2. 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.

    Time frame: Collected within 1 month of behavioral testing

  3. 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.

    Time frame: Collected within 1 month of MRI

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2023 (actual). Primary completion is estimated for Aug 2028, 67 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2024
First posted
Nov 21, 2024
StartActual
Jan 12, 2023
Primary completionEst.
Aug 31, 2028
CompletionEst.
Aug 31, 2028
Last update
Nov 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06700005
Collaborators
MedStar National Rehabilitation Network, National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Sponsor
First posted
Nov 21, 2024
Start date
Jan 12, 2023
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Nov 21, 2024

Study contacts

Alycia Laks, MS, CCC-SLP
Contact
crlab@georgetown.edu
202-687-5205
Peter Turkeltaub, MD,PhD
principal investigator · Georgetown University; MedStar National Rehabilitation Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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