NCT06068296

Brief Summary

Background and aim There is a growing awareness that people with aphasia (language problems) after a stroke often have difficulties with their short-term memory (STM). As a result, the explanation underlying aphasia has recently been seen as a language processing disorder, where multiple cognitive processes interact. To evaluate the cognitive processes underlying aphasia, there is a need for reliable and valid assessment tools. However, the quality of tests usually used to assess STM problems in aphasia patients is questioned because they are not specifically designed to be used in aphasia patients. This raises some concern, as impairments of STM can be predictive for the recovery and rehabilitation of aphasia patients. As an important exception, a recent study has developed a new English evaluation tool (i.e., The Temple Assessment of Language and (Verbal) Short-term Memory in Aphasia; TALSA) that examines language and STM aspects specifically developed for persons with aphasia. However, the existence of a Dutch evaluation tool specifically designed to assess language and STM problems in people with aphasia after a stroke is lacking. Therefore, the aim of the current study is to develop a Dutch clinical version of the TALSA battery that may lead to better diagnosis and treatment of STM problems in persons with aphasia. The development of the test focuses on its clinical feasibility (e.g. test duration, difficulty of the items and response modality). Pilot testing of the Dutch STM assessment instrument in the clinical and healthy population is very important to adapt the test where necessary. In addition, the quality of the test should also be carefully evaluated. Method The first step towards the development of a Dutch STM assessment instrument is the careful selection of the most crucial subtests of the original TALSA battery. Not all subtests will be selected due to the long testing time of the TALSA battery, and as mentioned earlier, the Dutch STM assessment tool focuses on clinical feasibility of the test. The second step is pilot testing the Dutch STM assessment instrument in persons with aphasia and healthy persons. Persons with aphasia will be recruited at the Stroke unit of Ghent University Hospital. All eligible patients will be asked to provide written informed consent to participate in this study. Three tests will be administered, namely the Oxford Cognitive Screen, the Token Test and the Dutch STM assessment tool. It is important that these tests are taken on the same day or on two consecutive days, depending on the circumstances (e.g. fatigue). The Token Test and Oxford Cognitive Screen provide a picture of the patient's cognitive profile. Throughout the process of pilot testing, the Dutch STM assessment tool will be adapted and improved where necessary. In order to verify or adjust the difficulty of the items, it is crucial that the STM assessment instrument is also tested on a small number of healthy control subjects (recruited via social media platforms).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

April 30, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

Same day

First QC Date

December 21, 2022

Last Update Submit

September 28, 2023

Conditions

Keywords

aphasiashort-term memoryassessment

Outcome Measures

Primary Outcomes (1)

  • verbal short-term memory in poststroke aphasia

    assessment of verbal short-term memory in patients with poststroke aphasia: feasability, psychometric properties and normative data

    2 hours

Study Arms (2)

Short term memory assessment in patients with aphasia.

OTHER

Evaluation of short term memory in a patient population with poststroke aphasia using a dutch version of the Temple Assessment of Language and Verbal Short-Term memory in aphasia (TALSA).

Diagnostic Test: short term memory assessmentDiagnostic Test: Oxford cognitive screenDiagnostic Test: Token Test

short term memory assessment in healthy volunteers

OTHER

Evaluation of short term memory in healthy volunteers using a dutch version of the Temple Assessment of Language and Verbal Short-Term memory in aphasia (TALSA).

Diagnostic Test: short term memory assessmentDiagnostic Test: Montreal cognitive assessment

Interventions

Aphasia group: The Dutch verbal STM assessment tool will be administered over a time span of maximum two consecutive days depending on how fatigued the patient is during testing. Healthy control group: the Dutch verbal STM assessment tool will be administered.

Short term memory assessment in patients with aphasia.short term memory assessment in healthy volunteers

Evaluation of the cognitive abilities of the patients with aphasia.

Short term memory assessment in patients with aphasia.
Token TestDIAGNOSTIC_TEST

Evaluation of the severity of the aphasia in patients with aphasia.

Short term memory assessment in patients with aphasia.

Evaluation of cognitive dysfunction in the group of healthy volunteers.

short term memory assessment in healthy volunteers

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aphasia after an initial ischemic or hemorrhagic stroke diagnosed by the speech pathologist and a screening instrument to evaluate aphasia (ScreeLing)
  • Age 18-85 years
  • Speak Dutch as a mother language
  • Acute to subacute phase poststroke
  • Signed informed consent

You may not qualify if:

  • There is a history of other diseases of the central nervous system causing non-stroke related speech-, language or cognitive disorder
  • They present severe sensory impairment or other co-morbidities prohibiting administration of the assessment tool
  • Excessive active alcohol or drug abuse
  • Transient ischemic attack (i.e., TIA)
  • Normal score (\> 26) on the Montreal Cognitive Assessment (MOCA)
  • Speak Dutch as a mother language
  • Have no history of stroke or other central nervous system diseases that affect speech, language or cognition
  • Have no severe auditory or visual disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (18)

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    PMID: 14026018BACKGROUND
  • Brysbaert M, Stevens M, Mandera P, Keuleers E. The impact of word prevalence on lexical decision times: Evidence from the Dutch Lexicon Project 2. J Exp Psychol Hum Percept Perform. 2016 Mar;42(3):441-58. doi: 10.1037/xhp0000159. Epub 2015 Oct 26.

    PMID: 26501839BACKGROUND
  • Dell GS, O'Seaghdha PG. Stages of lexical access in language production. Cognition. 1992 Mar;42(1-3):287-314. doi: 10.1016/0010-0277(92)90046-k.

    PMID: 1582160BACKGROUND
  • Dell GS, Schwartz MF, Martin N, Saffran EM, Gagnon DA. Lexical access in aphasic and nonaphasic speakers. Psychol Rev. 1997 Oct;104(4):801-38. doi: 10.1037/0033-295x.104.4.801.

    PMID: 9337631BACKGROUND
  • Demeyere N, Riddoch MJ, Slavkova ED, Bickerton WL, Humphreys GW. The Oxford Cognitive Screen (OCS): validation of a stroke-specific short cognitive screening tool. Psychol Assess. 2015 Sep;27(3):883-94. doi: 10.1037/pas0000082. Epub 2015 Mar 2.

    PMID: 25730165BACKGROUND
  • Harnish SM, Lundine JP. Nonverbal Working Memory as a Predictor of Anomia Treatment Success. Am J Speech Lang Pathol. 2015 Nov;24(4):S880-94. doi: 10.1044/2015_AJSLP-14-0153.

    PMID: 26383918BACKGROUND
  • Ivanova MV, Hallowell B. A tutorial on aphasia test development in any language: Key substantive and psychometric considerations. Aphasiology. 2013 Jan 1;27(8):891-920. doi: 10.1080/02687038.2013.805728.

    PMID: 23976813BACKGROUND
  • Lang CJ, Quitz A. Verbal and nonverbal memory impairment in aphasia. J Neurol. 2012 Aug;259(8):1655-61. doi: 10.1007/s00415-011-6394-1. Epub 2012 Jan 19.

    PMID: 22258478BACKGROUND
  • Martin N, Gupta P. Exploring the relationship between word processing and verbal short-term memory: evidence from associations and dissociations. Cogn Neuropsychol. 2004 Mar 1;21(2):213-28. doi: 10.1080/02643290342000447.

    PMID: 21038201BACKGROUND
  • Martin N, Minkina I, Kohen FP, Kalinyak-Fliszar M. Assessment of linguistic and verbal short-term memory components of language abilities in aphasia. J Neurolinguistics. 2018 Nov;48:199-225. doi: 10.1016/j.jneuroling.2018.02.006.

    PMID: 30220790BACKGROUND
  • Mayer JF, Murray LL. Measuring working memory deficits in aphasia. J Commun Disord. 2012 Sep-Oct;45(5):325-39. doi: 10.1016/j.jcomdis.2012.06.002. Epub 2012 Jun 16.

    PMID: 22771135BACKGROUND
  • Murray L, Salis C, Martin N, Dralle J. The use of standardised short-term and working memory tests in aphasia research: a systematic review. Neuropsychol Rehabil. 2018 Apr;28(3):309-351. doi: 10.1080/09602011.2016.1174718. Epub 2016 May 4.

    PMID: 27143500BACKGROUND
  • Seniow J, Litwin M, Lesniak M. The relationship between non-linguistic cognitive deficits and language recovery in patients with aphasia. J Neurol Sci. 2009 Aug 15;283(1-2):91-4. doi: 10.1016/j.jns.2009.02.315. Epub 2009 Mar 6.

    PMID: 19268973BACKGROUND
  • Bastiaanse, R, Wieling, M, Wolthuis, N. The role of frequency in the retrieval of nouns and verbs in aphasia. Aphasiology. 2016; 30(11): 1221-1239.

    BACKGROUND
  • Kay, J, Lesser, R, Coltheart, M. Psycholinguistic assessments of language processing in aphasia (PALPA): An introduction. Aphasiology. 1996; 10(2): 159-180.

    BACKGROUND
  • McNeil, MR, Pratt, SR. Defining aphasia: Some theoretical and clinical implications of operating from a formal definition. Aphasiology. 2001; 15(10-11): 901-911.

    BACKGROUND
  • Murray, LL. Direct and indirect treatment approaches for addressing short-term or working memory deficits in aphasia. Aphasiology. 2012; 26(3-4): 317-337.

    BACKGROUND
  • Dell GS, Martin N, Schwartz MF. A Case-Series Test of the Interactive Two-step Model of Lexical Access: Predicting Word Repetition from Picture Naming. J Mem Lang. 2007 May 1;56(4):490-520. doi: 10.1016/j.jml.2006.05.007.

    PMID: 21085621BACKGROUND

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

October 5, 2023

Study Start

April 30, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

October 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations