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AnomiaNCT03568760

Finding the Right Words in Neurogenic Communication Disorders

A study testing Semantic feature analysis and Comprehension training in people with Anomia and Stroke, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Every year thousands of persons suffer from brain damage resulting in anomia, that is, word finding difficulties affecting their ability to talk to other people. Anomia may be a result of stroke or of progressive neurological diseases such as Parkinson's disease or multiple sclerosis (MS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anomia, Stroke, Aphasia
What is being tested?
Semantic feature analysis and Comprehension training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteSweden
Study dates
1 Jan 2016to 31 Dec 2021
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjective experience of word finding difficulties
  • Diagnosed left hemisphere stroke or Parkinson's disease or MS
  • With correction, sufficient hearing and vision to be able to participate in the assessment
  • Participants with stroke at least six months post-onset and documented location of injury.

Who cannot join

  • Mother tongue other than Swedish
  • Moderately or severely impaired comprehension
  • Other neurological injury or disease
  • Moderate-severe apraxia of speech or dysarthria
  • Fatigue or impaired attention deficit which prevents participating in intensive training

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • University of Gothenburg

    Gothenburg, Västra Göraland, 405 30

Other trials in Sweden

About this study

Official title: Finding the Right Words in Neurogenic Communication Disorders: Naming of Objects and Actions, Communicative Strategies in Conversation and Effects of Training

Every year thousands of persons suffer from brain damage resulting in anomia, that is, word finding difficulties affecting their ability to talk to other people. Anomia may be a result of stroke or of progressive neurological diseases such as Parkinson's disease or multiple sclerosis (MS). Word retrieval is dependent on a complex system of different neural networks and to name objects and activities can be affected to different degrees. The present project explores different aspects of naming ability in altogether 90 persons that has anomia related to stroke or to Parkinson's disease or MS. Furthermore, the communicative strategies and resources used by conversation partners in everyday conversational interaction and in care situations, affected by anomia are studied. Finally, the project includes a study of the effectiveness of a word finding training program based on stimulation of semantic and phonological networks in the brain, involved in the production of words. There is a lack of research on effects on communication from anomia in Parkinson's disease and MS and there is no research on anomia that investigates both object and action naming using a material adapted to the Swedish language. In the project quantitative and qualitative methods are used to explore and describe how persons with different neurogenic communication disorders can use different resources and communicative strategies to express themselves.

Read the detailed description

Project out line

The main project consists of:

  1. A descriptive study of the occurrence and type of naming difficulties in people with stroke, Parkinson's disease or Multiple sclerosis (MS) where quantitative data is compared at group level, (study 1).
  2. A descriptive study in which word search strategies are investigated with both quantitative and qualitative methods (study 2).
  3. A series of three intervention studies examining the effect of treatment of anomia (studies 3-5).

Study 1: The relation between type of injury and ability to name objects and actions and complex semantic-pragmatic word fluency

Participants The project includes a total of 90 people with anomia: 50 subjects with anomia after stroke, 20 individuals with Parkinson's disease and 20 individuals with MS are recruited are recruited through patient associations and health care facilities in Västra Götaland and included consecutively.

In the study confrontation naming ability, and word fluency is explored. In addition, the type of naming difficulties and consequences of anomia in everyday communication are examined with a questionnaire and communication analysis.

  1. Confrontation naming ability is examined with a material consisting of 42 images representing 21 nouns and 21 verbs. The selection of images comes from The Object \& Action Naming Battery and is adapted to Swedish linguistic and cultural conditions. The images consist of simple black and white drawings. There is a 20-second time limit for response for each image. In addition to scoring, an analysis and categorization of the response according to the coding scheme is performed; 2) Word fluency is examined with semantic (animals and activities) and phonological (F, A and S) word fluency tests where the participant will produce as many words as possible for each category during one minute. The results are compared with reference data for healthy participants and the use of strategies is analyzed by calculating cluster size and number of switches between different categories; a more complex semantic-pragmatic word fluency task is also administrated.

Participants' experience of their communication skills in everyday life and quality of life is gathered in a questionnaire with image support: The Communication Outcome After Stroke (COAST) scale. COAST consists of 20 questions where participants estimate themselves on a 5-degree likert scale. Stroke and Aphasia Quality of Life Scale (SAQOL-39) and Communicative Participation Item Bank (CPIB) are also administrated as well as a formalized interview.

Study 2: Word search strategies in naming difficulties in people with different types of neurogenic communication disorders

Participants In this descriptive study fifteen participants with Parkinson's disease and fifteen participants with MS are included.

Material and methods Word search strategies in ten-twenty minutes of naturally occurring conversations are assessed through communication analysis. Sequences where participants are involved in repair due to difficulties to express themselves are analyzed with the qualitative method Conversation Analysis in combination med Aktivity based communication analysis.

Studies 3-4: Training with semantic feature analysis to improve naming

Participants Six participants with MS and six participants with Parkinson's disease and 40 participants with anomia due to stroke will be included.

Intervention Participants receive training in semantic feature analysis (SFA) for naming of objects and activities. The training is administered by presenting an image representing either an object or an activity are presented to the participant. The participant is encouraged to try to produce the target word as well as a number of words semantically related to the target word. The related words are listed in a certain order and describe different semantic aspects of the target word. The participants get to choose a number of words which they want to practice.

The participants receive training at 20 occasions, three times a week. The training is delivered during one hour each session in individual training for the participants with MS and in a group setting for two hours, including 30 minutes pause for participants with stroke

Study 3-4 - training anomia due to Parkinson's disease and MS Since semantic feature analysis has not previously been used as treatment for people with Parkinson's disease or MS, the effect is evaluated in using time series design with multiple baselines. Three-five baseline measures of the dependent variable is collected before start of training and then every fourth training session.

Study 5 - training anomia due to stroke In study 5 the effect of intervention for participants with anomia due to stroke is assessed in a randomized group study with a control group. The control group receives training in comprehension. The groups are matched in terms of age, severity of anomia time since onset and level of education. Before and after the intervention, as well as at a twelve week follow up, the effects are assessed in both groups.

Being tested
Semantic feature analysis, Comprehension training
Keywords
Anomia
Medical subject headings
Anomia, Stroke, Aphasia, Parkinson Disease, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semantic feature analysisBehavioural

    Confrontation naming training and training in doing circumlocutions

  • Comprehension trainingBehavioural

    Reading and hearing comprehension

Study groups in NCT03568760
Study groupRoleWhat they receive
SFA treatmentExperimentalSemantic feature analysis
Receives: Behavioral: Semantic feature analysis
Comprehension trainingPlacebo comparatorComprehension training
Receives: Behavioral: Comprehension training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Naming ability in the Object & Action Naming Battery

    A measure of change in ability to name forty pictures consisting of simple black and white drawings. There is a 20-second time limit for response for each picture. Number of correct objects and activities will be calculated separately (range 0-20) as well as summarized (range 0-40)

    Measured: At baseline before start of intervention and after 21 days, at completion the intervention program

Secondary outcomes (11)
  1. Sustained change in naming ability in the Object & Action Naming Battery

    A measure of change in ability to name forty pictures consisting of simple black and white drawings. There is a 20-second time limit for response for each picture. Number of correct objects and activities will be calculated separately (range 0-20) as well as summarized (range 0-40)

    Measured: At a twelve week follow up after the completion of the intervention

  2. Naming of 20 individually chosen training words

    A measure of change in ability to name objects and action words participants have chosen to practice

    Measured: At baseline before start of intervention and after 21 days, at completion the intervention program

  3. Sustained change in naming of 20 individually chosen training words

    A measure of change in ability to name objects and action words participants have chosen to practice

    Measured: At a twelve week follow up after the completion of the intervention

  4. The Communication Outcome After Stroke (COAST) scale

    A measure of change in participants perception of the communicative ability from baseline to after intervention. COAST comprises 20 items where participants rates themselves on a 5-graded likert scale. The scale is running from 1) "couldn't do it at all, through 2) "with a lot of difficulty", 3) "with some difficulty", 4) "quite well" to 5) "very well". The scoring of each item will be summarized and averaged (total range 0-5) and a higher score indicates perceptions of better communicative ability.

    Measured: At baseline before start of intervention and after 21 days, at completion the intervention program

  5. Sustained change in the Communication Outcome After Stroke (COAST) scale

    A measure of change in participants perception of the communicative ability twelve weeks after intervention is completed. COAST comprises 20 items where participants rates themselves on a 5-graded likert scale. The scale is running from The scale is running from 1) "couldn't do it at all, through 2) "with a lot of difficulty", 3) "with some difficulty", 4) "quite well" to 5) "very well". The scoring of each item will be summarized and averaged (total range 0-5) and a higher score indicates perceptions of better communicative ability.

    Measured: At a twelve week follow up after the completion of the intervention

  6. The Stroke Aphasia Quality of Life (SAQOL-39)

    A measure of change after intervention in participant reported health related quality of life in a questionnaire with 39 items where participants evaluate of their everyday functioning in three domains: physical, psychosocial and communication. Scores range from 1 to 5 in each sub domain and are averaged; higher scores indicate better quality of life. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score (range 1-5).

    Measured: At baseline before start of intervention and after 21 days, at completion the intervention program

  7. Sustained change in the Stroke Aphasia Quality of Life (SAQOL-39)

    A measure of change 12 weeks after intervention is completed in participant reported health related quality of life in a questionnaire with 39 items where participants evaluate of their everyday functioning in three domains: physical, psychosocial and communication. Scores range from 1 to 5 in each sub domain and are averaged; higher scores indicate better quality of life. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score (range 1-5).

    Measured: At a follow up twelve weeks after completion of intervention

  8. The Communicative Participation Item Bank (CPIB)

    A measure of change from baseline to after intervention in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used - participants rates their perception of degree of participation on a four-graded scale where higher scores indicate higher degree of participation. The scale runs from 0) "very much", through 1) "quite a bit", 2) "a little", to 3) "not at all". The scoring of each item will be summarized into a total score (range 0-30).

    Measured: At baseline before start of intervention and after 21 days, at completion the intervention program

  9. Sustained change in the Communicative Participation Item Bank (CPIB)

    A measure of change 12 weeks after the completion of the intervention in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used - participants rates their perception of degree of participation on a four-graded scale where higher scores indicate higher degree of participation. The scale runs from 0) "very much", through 1) "quite a bit", 2) "a little", to 3) "not at all". The scoring of each item will be summarized into a total score (range 0-30).

    Measured: At a 12 week follow up after the completion of the intervention

  10. Retelling of events in video clips

    A measure of change in ability to retell and describe events from baseline to after intervention is completed.The participants view short video clips with a character involved with different activities including objects and are asked to retell what happened every tenth second.

    Measured: At baseline before start of intervention and after 21 days, at completion the intervention program

  11. Sustained change in retelling of events in video clips

    A measure of change in ability to retell and describe events from after the completion of intervention to a 12 weeks follow up. The participants view short video clips with a character involved with different activities including objects and are asked to retell what happened every tenth second.

    Measured: At a 12 week follow up after the completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start1 Jan 2016
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03568760
Sponsor's protocol ID
2016-01275
Other IDs
2016
Status last verified
Mar 2022
First submitted
21 May 2018
Last updated
16 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tallberg IM, Ivachova E, Jones Tinghag K, Ostberg P. Swedish norms for word fluency tests: FAS, animals and verbs. Scand J Psychol. 2008 Oct;49(5):479-85. doi: 10.1111/j.1467-9450.2008.00653.x. Epub 2008 Apr 29.

    PubMed 18452499
  • 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.

    PubMed 19052247
  • 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.

    PubMed 23816661
  • 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.

    PubMed 19447841

Questions about this trial

What is this clinical trial studying?

A study testing Semantic feature analysis and Comprehension training in people with Anomia and Stroke, run by Göteborg University at 1 site in Sweden.

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 4 inclusion and 5 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 16 Mar 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 Sweden. 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. Some participants in this study may receive a placebo. 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?

Naming ability in the Object & Action Naming Battery (time frame: At baseline before start of intervention and after 21 days, at completion the intervention program). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03568760, which also lists 4 linked publications.

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 16 Mar 2022.

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