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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03635554
Other study ID # TempleU2
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 15, 2017
Est. completion date November 30, 2025

Study information

Verified date April 2024
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Over five years, we will develop a clinically feasible test that can be used to assess in-depth the language and verbal short-term memory abilities of individuals with aphasia (Called the TALSA - Temple Assessment of Language and Short-term memory in Aphasia. Based on a test that we have developed and tested over the past decade, we will create a shorter version that can be used by clinicians in a rehabilitation setting. The data to support this development will come from two sources: (1) clinicians in rehabilitation facilities who will use the new clinical test and provide feedback on the test (administration, value etc) and (2) people with aphasia who will be administered the longer version to help us identify the best test items in the laboratory version of the TALSA to be carried over to the shorter clinical version. We are recruiting individuals with aphasia as well as people without aphasia (to serve as controls) to help with development of this assessment battery. The battery consists of between 15 and 20 subtests that assess many aspects of language and verbal short-term memory.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date November 30, 2025
Est. primary completion date November 30, 2025
Accepts healthy volunteers
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria: - . 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. Exclusion Criteria: English as a second language Right hemisphere stroke Less than 6 months post-onset of stroke.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Temple University Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Temple University University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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