AnomiaETAT PSANCT05101408
Executive Training and Anomia Therapy in Chronic Post-stroke Aphasia
An observational study of Anomia and Post-stroke Aphasia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Aphasia is a devastating acquired language impairment mainly caused by stroke, in which anomia is a quintessential clinical feature. If speech-language therapy (SLT) has been shown to be effective for persons with aphasia, the relative efficiency of one SLT strategy over another remains a matter of debate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anomia, Post-stroke Aphasia
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 30 Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Person with post-stroke aphasia at the chronic stage, receiving SLT rehabilitation
Who may be able to join
- 18 < age > 80 years
- adult person with chronic post-stroke aphasia (> 6 months postonset)
- receiving SLT rehabilitation 3 times a Week
Who cannot join
- presence of apraxia of speech
- major impairment of comprehension
- history of other neurological or psychiatric disease
- presence of apraxia of speech
- presence of major impairment of comprehension
- presence of history of other neurological or psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining Executive Training and Anomia Therapy in Chronic Post-stroke Aphasia : a Single Case Experimental Design -SCED Preliminary Study
Aphasia is a devastating acquired language impairment mainly caused by stroke, in which anomia is a quintessential clinical feature. If speech-language therapy (SLT) has been shown to be effective for persons with aphasia, the relative efficiency of one SLT strategy over another remains a matter of debate. The influential relationship between language, executive functions and aphasia rehabilitation outcomes has been addressed in a number of studies, but only few of them have studied the effect of adding an executive training to linguistic therapies.The aim of this study is to measure the efficiency of a protocol combining anomia therapy and executive training on naming skills and discourse in post-stroke aphasic persons at the chronic stage
- Conditions
- Anomia, Post-stroke Aphasia
- Keywords
- Aphasia, Speech-Language Therapy, Anomia, Executive functions
- Medical subject headings
- Anomia, Aphasia, Communication Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of individual naming scores
Evolution of individual naming scores during baseline and treatment phases Participants are asked to name pictures from a personal naming task constituted of 100 black and white pictures and scores are expressed as percent of correct responses (min 0, max 100): higher percents meaning a better outcome. A visual analysis of the evolution of these scores along the course of the treatment will be conducted.
Measured: 2 days
Comparison of discourse
Comparison of discourse scores before and after the treatment For each participant, four different samples of discourse are elicited before and after the treatment (picture description, personal narrative, book supported narrative, procedural information). The mean number of correct words per minute is then computed for each participant, and compared between the two time points, higher scores meaning a better outcome.
Measured: 2 days
Secondary outcomes (1)
Comparison of executive scores
Comparison of executive scores before and after the treatment Executive scores are computed before and after treatment for each participant, from the Modified Card Sorting Test (Nelson, 1976), in which higher number of categories achieved means a better outcome, and from a verbal fluency task in which higher number of words produced in 2 minutes means a better outcome
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnomiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie Moritz-Gasser, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101408
- Sponsor's protocol ID
- RECHMPL21_0597
- Acronym
- ETAT PSA
- Status last verified
- Apr 2022
- First submitted
- 19 Oct 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Executive Training and Anomia Therapy in Chronic Post-stroke Aphasia : a Single Case Experimental Design -SCED Preliminary Study
- ClinicalTrials.gov ID
- NCT05101408
- Acronym / sponsor ID
- ETAT PSA / RECHMPL21_0597
- Conditions
- Anomia, Post-stroke Aphasia
- Keywords
- Aphasia, Speech-Language Therapy, Anomia, Executive functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 1 Nov 2021 (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.
Aphasia is a devastating acquired language impairment mainly caused by stroke, in which anomia is a quintessential clinical feature. If speech-language therapy (SLT) has been shown to be effective for persons with aphasia, the relative efficiency of one SLT strategy over another remains a matter of debate. The influential relationship between language, executive functions and aphasia rehabilitation outcomes has been addressed in a number of studies, but only few of them have studied the effect of adding an executive training to linguistic therapies.The aim of this study is to measure the efficiency of a protocol combining anomia therapy and executive training on naming skills and discourse in post-stroke aphasic persons at the chronic stage
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Person with post-stroke aphasia at the chronic stage, receiving SLT rehabilitation
Key inclusion criteria (3 listed)
- 18 < age > 80 years
- adult person with chronic post-stroke aphasia (> 6 months postonset)
- receiving SLT rehabilitation 3 times a Week
Key exclusion criteria (6 listed)
- presence of apraxia of speech
- major impairment of comprehension
- history of other neurological or psychiatric disease
- presence of apraxia of speech
- presence of major impairment of comprehension
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
Evolution of individual naming scores
Time frame: 2 days
Evolution of individual naming scores during baseline and treatment phases Participants are asked to name pictures from a personal naming task constituted of 100 black and white pictures and scores are expressed as percent of correct responses (min 0, max 100): higher percents meaning a better outcome. A visual analysis of the evolution of these scores along the course of the treatment will be conducted.
Comparison of discourse
Time frame: 2 days
Comparison of discourse scores before and after the treatment For each participant, four different samples of discourse are elicited before and after the treatment (picture description, personal narrative, book supported narrative, procedural information). The mean number of correct words per minute is then computed for each participant, and compared between the two time points, higher scores meaning a better outcome.
1 secondary outcome
Comparison of executive scores
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
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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.
Sylvie Moritz-Gasser principal investigator
University Hospital, Montpellier
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 Anomia and Post-stroke Aphasia, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 12 Apr 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of individual naming scores (time frame: 2 days). The study lists 2 primary outcomes in all. 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 12 Apr 2022.