AphasiaClinTALSANCT03635554
Translation and Clinical Implementation of a Test of Language and Short-term Memory in Aphasia
An observational study of Aphasia, run by Temple University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Aphasia
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- . 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.
Who cannot join
- English as a second language Right hemisphere stroke Less than 6 months post-onset of stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation and Clinical Implementation of a Test for Language and Short-term Memory in Aphasia
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.
Read the detailed 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.
- Conditions
- Aphasia
- Keywords
- Aphasia
- Medical subject headings
- Aphasia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two to three years December 1, 2017 through December 15, 2017 through November 30, 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Dec 2017
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Nadine Martin, Temple University
- Investigators
- Nadine Martin, Ph.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635554
- Sponsor's protocol ID
- TempleU2
- Acronym
- ClinTALSA
- Status last verified
- Apr 2024
- First submitted
- 15 Aug 2018
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Clinical Implementation of a Test for Language and Short-term Memory in Aphasia
- ClinicalTrials.gov ID
- NCT03635554
- Acronym / sponsor ID
- ClinTALSA / TempleU2
- Conditions
- Aphasia
- Keywords
- Aphasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- . 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.
Key exclusion criteria (1 listed)
- English as a second language Right hemisphere stroke Less than 6 months post-onset of stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportions correct on subtests of the Test of Language and Short-term Memory in Aphasia (TALSA)
Time frame: two to three years December 1, 2017 through December 15, 2017 through November 30, 2022.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine Martin, Ph.D. principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphasia, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions correct on subtests of the Test of Language and Short-term Memory in Aphasia (TALSA) (time frame: two to three years December 1, 2017 through December 15, 2017 through November 30, 2022.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.