NCT06700005

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jan 2023Aug 2028

Study Start

First participant enrolled

January 12, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

November 21, 2024

Status Verified

October 1, 2024

Enrollment Period

5.6 years

First QC Date

November 6, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

aphasiastrokebrain injuryspeechlanguagereadingalexiaapraxia

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

RECRUITING

MeSH Terms

Conditions

AphasiaStrokeDyslexiaBrain InjuriesSpeechLanguageApraxias

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesSpecific Learning DisorderLearning DisabilitiesNeurodevelopmental DisordersMental DisordersCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesVerbal BehaviorCommunicationBehaviorPsychomotor Disorders

Study Officials

  • Peter Turkeltaub, MD,PhD

    Georgetown University; MedStar National Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alycia Laks, MS, CCC-SLP

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 21, 2024

Study Start

January 12, 2023

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

November 21, 2024

Record last verified: 2024-10

Locations