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Finding the Right Words in Neurogenic Communication Disorders

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ClinicalTrials.gov Identifier: NCT03568760
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
The Swedish Research Council
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Göteborg University

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Anomia Stroke Aphasia Parkinson Disease Multiple Sclerosis Behavioral: Semantic feature analysis Behavioral: Comprehension training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The results are assessed by independent assessors blinded to when the data is obtained and from which group.
Primary Purpose: Treatment
Official Title: Finding the Right Words in Neurogenic Communication Disorders: Naming of Objects and Actions, Communicative Strategies in Conversation and Effects of Training
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SFA treatment
Semantic feature analysis
Behavioral: Semantic feature analysis
Confrontation naming training and training in doing circumlocutions

Placebo Comparator: Comprehension training
Comprehension training
Behavioral: Comprehension training
Reading and hearing comprehension




Primary Outcome Measures :
  1. 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 ]
    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)


Secondary Outcome Measures :
  1. Sustained change in naming ability in the Object & Action Naming Battery [ Time Frame: At a twelve week follow up after the completion of the intervention ]
    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)

  2. Naming of 20 individually chosen training words [ Time Frame: At baseline before start of intervention and after 21 days, at completion the intervention program ]
    A measure of change in ability to name objects and action words participants have chosen to practice

  3. Sustained change in naming of 20 individually chosen training words [ Time Frame: At a twelve week follow up after the completion of the intervention ]
    A measure of change in ability to name objects and action words participants have chosen to practice

  4. The Communication Outcome After Stroke (COAST) scale [ Time Frame: At baseline before start of intervention and after 21 days, at completion the intervention program ]
    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.

  5. Sustained change in the Communication Outcome After Stroke (COAST) scale [ Time Frame: At a twelve week follow up after the completion of the intervention ]
    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.

  6. The Stroke Aphasia Quality of Life (SAQOL-39) [ Time Frame: At baseline before start of intervention and after 21 days, at completion the intervention program ]
    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).

  7. Sustained change in the Stroke Aphasia Quality of Life (SAQOL-39) [ Time Frame: At a follow up twelve weeks after completion of intervention ]
    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).

  8. The Communicative Participation Item Bank (CPIB) [ Time Frame: At baseline before start of intervention and after 21 days, at completion the intervention program ]
    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).

  9. Sustained change in the Communicative Participation Item Bank (CPIB) [ Time Frame: At a 12 week follow up after the completion of the intervention ]
    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).

  10. Retelling of events in video clips [ Time Frame: At baseline before start of intervention and after 21 days, at completion the intervention program ]
    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.

  11. Sustained change in retelling of events in video clips [ Time Frame: At a 12 week follow up after the completion of the intervention ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568760


Contacts
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Contact: Charlotta Saldert +46317866885 charlotta.saldert@neuro.gu.se
Contact: Joana Kristensson joana.kristensson@vgregion.se

Locations
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Sweden
University of Gothenburg Recruiting
Gothenburg, Västra Göraland, Sweden, 405 30
Contact: Joana Kristensson    +46313425560    joana.kristensson@vgregion.se   
Contact: Charlotta Saldert    +46317866885    charlotta.saldert@neuro.gu.se   
Sponsors and Collaborators
Göteborg University
The Swedish Research Council
Swedish Council for Working Life and Social Research
Investigators
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Principal Investigator: Charlotta Saldert Inst of Neurosci & Physiology, Speech & Language Pathology Unit University of Gothenburg

Publications:
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03568760     History of Changes
Other Study ID Numbers: 2016-01275
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Anomia
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Aphasia
Anomia
Communication Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Speech Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders