NCT03568760

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

6 years

First QC Date

May 21, 2018

Last Update Submit

March 15, 2022

Conditions

Keywords

Anomia

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (11)

  • Sustained change in naming ability in the Object & Action Naming Battery

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

  • Naming of 20 individually chosen training words

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

  • Sustained change in naming of 20 individually chosen training words

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

  • The Communication Outcome After Stroke (COAST) scale

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

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

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

  • +6 more secondary outcomes

Study Arms (2)

SFA treatment

EXPERIMENTAL

Semantic feature analysis

Behavioral: Semantic feature analysis

Comprehension training

PLACEBO COMPARATOR

Comprehension training

Behavioral: Comprehension training

Interventions

Confrontation naming training and training in doing circumlocutions

SFA treatment

Reading and hearing comprehension

Comprehension training

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, Västra Göraland, 405 30, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 18452499BACKGROUND
  • 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.

    PMID: 19052247BACKGROUND
  • 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.

    PMID: 23816661BACKGROUND
  • 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.

    PMID: 19447841BACKGROUND

MeSH Terms

Conditions

AnomiaStrokeAphasiaParkinson DiseaseMultiple Sclerosis

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Charlotta Saldert

    Inst of Neurosci & Physiology, Speech & Language Pathology Unit University of Gothenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The results are assessed by independent assessors blinded to when the data is obtained and from which group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 26, 2018

Study Start

January 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations