NCT06405594

Brief Summary

The proposed research is relevant to public health because stroke is a leading cause of long-term disability among older adults and communication impairments resulting from stroke have a significant negative impact on quality of life. By seeking to better understand post-stroke aphasia, this project lays the groundwork for development of new interventions, and aligns with NIDCD's priority areas 1 (understanding normal function), 2 (understanding diseases), and 3 (improving diagnosis, treatment, and prevention).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started Aug 2024

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress37%
Aug 2024Jun 2029

First Submitted

Initial submission to the registry

May 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

3.8 years

First QC Date

May 1, 2024

Last Update Submit

August 28, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Accuracy

    Response accuracy for each experimental condition will be measured

    through the completion of the study, an average of 1 year

  • Response time

    Response times for each experimental condition will be measured

    through the completion of the study, an average of 1 year

  • Brain activity

    Patterns of brain activity (using magnetoencephalography and MRI) will be measured for each experimental condition

    through the completion of the study, an average of 1 year

Study Arms (1)

Language condition

EXPERIMENTAL

All participants will receive this arm. In this arm, the intervention involves asking participants to speak and understand words and sentences with different linguistic manipulations such as morphological, semantic, phonological priming, predictability of the subject and object nouns associated with verbs, naming of verbs and nouns, production of sentences with past, future or present tense. Accuracy, response times and brain activity are the outcome measures.

Behavioral: Language Condition

Interventions

The intervention involves asking participants to speak and understand words and sentences with different linguistic manipulations such as morphological, semantic, phonological priming, predictability of the subject and object nouns associated with verbs, naming of verbs and nouns, production of sentences with past, future or present tense. Accuracy, response times and brain activity are the outcome measures.

Language condition

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • Persons with acquired aphasia are defined as those with a language impairment following left hemisphere brain injury (most likely a stroke).
  • Neurotypical adults need to be either young (ages 18-30 years) or older (\> 60 years)
  • Native (or primary) speakers of English

You may not qualify if:

  • Prior neurological or psychiatric diagnoses or developmental disabilities before the onset of aphasia
  • do not speak English fluently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

College Park, Maryland, 20742, United States

RECRUITING

MeSH Terms

Conditions

AphasiaStroke

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yasmeen Faroqi-Shah, PhD

    University of Maryland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmeen Faroqi-Shah, PhD

CONTACT

Robert Slevc, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants will receive the same intervention (language condition) and a single arm (language condition)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 8, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

September 3, 2024

Record last verified: 2024-08

Locations