NCT03635554

Brief Summary

This project aims to develop a clinically feasible version of a laboratory-developed assessment battery for language and verbal short-term memory difficulties in aphasia.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Start

First participant enrolled

December 15, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

8 years

First QC Date

August 15, 2018

Last Update Submit

April 9, 2024

Conditions

Keywords

Aphasia

Outcome Measures

Primary Outcomes (1)

  • Proportions correct on subtests of the Test of Language and Short-term Memory in Aphasia (TALSA)

    Participants will be administered 15-20 subtests of the TALSA that assess aspects of language (phoneme discrimination, sentence comprehension) and short-term memory (e.g., repetition span) abilities. Their responses on these measures will be evaluated in a item response analysis to determine which items are ideal to use in a smaller version of this test that is feasible to use in clinical practice. Another group of people with aphasia will be administered the clinical version (when it is complete) to develop normative data for that assessment battery.

    two to three years December 1, 2017 through December 15, 2017 through November 30, 2022.

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with aphasia will have single or multiple left hemisphere lesions, but no right hemisphere lesions. They can be between the ages of 21 and 80. Their aphasia can range in severity from mild to severe and can be of any type except global aphasia. Their language output can be fluent or nonfluent and their comprehension can be mild moderately impaired.

You may qualify if:

  • single or multiple left hemisphere lesions
  • at least one year post-stroke.
  • high-school educated
  • negative histories for mental illness and alcohol/substance abuse.
  • passed an audiometric pure-tone, air conduction screening at 25 dB HL at 1K, 2K and 4K Hz for at least one ear.

You may not qualify if:

  • English as a second language Right hemisphere stroke Less than 6 months post-onset of stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nadine Martin, Ph.D.

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Communication Sciences and Disorders

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 17, 2018

Study Start

December 15, 2017

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations