Clinical trial NCT05152979: Effects of Verb Network Strengthening Treatment (VNeST) on Word Finding in Aphasia
Official title: Effects of On-line and In-clinic Intervention With Verb Network Strengthening Treatment (VNeST) on Word Finding in Aphasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anomia
Aphasia
Stroke
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2021-12-10
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: Although there is evidence that speech-language therapy may improve speech in language disorders following left hemisphere stroke there is still a lack of evidence for which types of therapy are effective. Furthermore, in Sweden, as well as in several other countries, access to speech-language therapy is limited. The purpose of this clinical trial is to compare outcome from Verb Network Strengthening Treatment (VNeST) provided as In-Clinic therapy (I-CT) or as synchronous telepractice therapy (TP-T).

Detailed description: Every year thousands of persons in Sweden suffer from brain damage resulting in anomia, that is, word finding difficulties affecting their ability to talk to other people. Anomia is one of the most common and persistent symptoms of aphasia following a left hemisphere stroke, but it is also common in in progressive neurological diseases such as Parkinson's disease or multiple sclerosis (MS). There is evidence that more intensive speech language therapy may improve speech even in a chronic (\> six month post stroke) phase of aphasia. However, access to the necessary amount of speech language therapy is limited due to lack of financial resources as well as to limitations to service providers in more rural areas.

It has been suggested that telepractice may increase the access to speech-language therapy for more people but there is a lack of knowledge of whether there is a difference in outcome from interventions provided as In-Clinic therapy (I-CT) or as telepractice therapy (TP-T).

Verb Network Strengthening Treatment (VNeST) is an anomia therapy focused on the production of short phrases. The participants generate thematically related verbs and nouns to strengthen the neural connections between the action (verb) and related thematic roles (agents and patients). From orally and written stimuli, the participants are asked to tell whom (subject) may do something (verb) with what (object) and then to do short expansions from this basic phrase. So far, results from single-case experimental design studies performed by Edmonds and colleagues are promising, showing generalization of outcomes to untrained items. Moreover, improvement in word finding was observed in other tasks like object and verb naming as well as sentence production and partly to connected speech.

The present project explores the effectiveness of VNeST, first in a small pilot study, then in a clinical trial including 80 participants. Participants with left hemisphere aphasia will be randomized to either an in-clinic therapy (I-CT) group or a telepractice therapy (TP-T) group and provided VNeST following the same treatment protocol based on Edmonds (2014).

Outcome measure include measures of naming ability on word- and phrase levels as well as in discourse. Measures of participant reported perceptions of functional communication and communicative participation as well as health related quality of life (PROMs) are also included.

Eligibility criteria: Inclusion Criteria:

* Aphasia and subjective experience of word finding difficulties
* Diagnosed left-hemisphere stroke at least six months post-onset
* With correction, sufficient hearing and vision to be able to participate in training and assessment
* Primarily speaking Swedish for at least the last 15 years

Exclusion Criteria:

* Other neurological injury or disease
* Moderately or severely impaired comprehension
* Moderate-severe apraxia of speech or dysarthria which may interfere with assessment
* Participation in any other speech-language treatment during the study
* Active substance dependence

Primary outcomes:
measure: Change from baseline in naming ability of trained items at week 10.
timeFrame: Baseline, 10 weeks.
measure: Change from baseline in naming ability of trained items at week 20.
timeFrame: Baseline, 20 weeks.
Secondary outcomes:
measure: Change from baseline in naming ability of untrained items at week 10.
timeFrame: Baseline, 10 weeks.
measure: Change from baseline in naming ability of untrained items at week 20.
timeFrame: Baseline, 20 weeks.
measure: Change from baseline in confrontation naming of single words (objects and actions) at week 10.
timeFrame: Baseline, 10 weeks.
measure: Change from baseline in confrontation naming of single words (objects and actions) at week 20.
timeFrame: Baseline, 20 weeks.
measure: Change from baseline in confrontation naming of single words (objects) at week 10.
timeFrame: Baseline, 10 weeks.
measure: Change from baseline in confrontation naming of single words (objects) week 20.
timeFrame: Baseline, 20 weeks.
measure: Change from baseline in connected speech at week 10.
timeFrame: Baseline, 10 weeks.
measure: Change from baseline in connected speech at week 20.
timeFrame: Baseline, 20 weeks.
measure: Change from baseline in self reported communicative participation in everyday life at week 10.
timeFrame: Baseline, 10 weeks.
measure: Change from baseline in self reported communicative participation in everyday life at week 20.
timeFrame: Baseline, 20 weeks.
measure: Change from baseline in self reported quality of life at week 10.
timeFrame: Baseline, 10 weeks.
measure: Change from baseline in self reported quality of life at week 20.
timeFrame: Baseline, 20 weeks.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: University of Gothenburg, Västra Götalandsregionen
state: Västra Götaland
Study officials:
affiliation: Inst of Neurosci & Physiology, Speech & Language Pathology Unit, University of Gothenburg
name: Charlotta Saldert, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baylor C, Yorkston K, Eadie T, Kim J, Chung H, Amtmann D. The Communicative Participation Item Bank (CPIB): item bank calibration and development of a disorder-generic short form. J Speech Lang Hear Res. 2013 Aug;56(4):1190-208. doi: 10.1044/1092-4388(2012/12-0140). Epub 2013 Jul 1.
citation: Edmonds LA. Tutorial for Verb Network Strengthening Treatment (VNeST): Detailed Description of the Treatment Protocol with Corresponding Theoretical Rationale. Perspectives on Neurophysiology & Neurogenic Speech & Language Disorders. 2014; 24(3): 78-88
citation: Goodglass H, Kaplan E, Weintraub S. Boston Naming Test. Philadelphia, PA: Lea & Febiger. 1983.
citation: Hilari K, Lamping DL, Smith SC, Northcott S, Lamb A, Marshall J. Psychometric properties of the Stroke and Aphasia Quality of Life Scale (SAQOL-39) in a generic stroke population. Clin Rehabil. 2009 Jun;23(6):544-57. doi: 10.1177/0269215508101729. Epub 2009 May 15.
citation: Long A, Hesketh A, Paszek G, Booth M, Bowen A. Development of a reliable self-report outcome measure for pragmatic trials of communication therapy following stroke: the Communication Outcome after Stroke (COAST) scale. Clin Rehabil. 2008 Dec;22(12):1083-94. doi: 10.1177/0269215508090091.
citation: Masterson J, Druks J. Description of a set of 164 nouns and 102 verbs matched for printed word frequency, familiarity and age-of-acquisition. Journal of Neurolinguistics. 1998; 11: 331-54.
citation: Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.