Speeded Anomia Treatment in Chronic Post-stroke Aphasia
Primary Purpose
Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Speeded anomia therapy
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring Anomia, Speech Disorders, Language Disorders, Communication Disorders
Eligibility Criteria
Inclusion Criteria:
- Native English speakers
- Age 18 years or above
- Stroke (any type) greater than 12 months post onset
- No history of neurological disorders / psychiatric disorders
- Normal or corrected-to-normal hearing & vision
- Able to give informed consent
- Currently not receiving Speech & Language therapy
- Minimal repetition skills (>40% on an immediate word repetition test)
- Evidence of naming difficulties (<90% in Boston Naming Test - Goodglass et al., 1983)
Exclusion Criteria:
- Non-native English speakers
- Less than 18 years old
- Stroke less than 12 months post onset
- History of neurological disorders / psychiatric disorders
- Uncorrected hearing & vision
- Unable to give informed consent
- Currently receiving Speech & Language therapy
- Insufficient repetition skills (<40% on an immediate word repetition test)
- Good naming performance (>90% in Boston Naming Test - Goodglass et al., 1983)
Sites / Locations
- MRC Cognition & Brain Sciences UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Speeded anomia therapy
Standard care
Arm Description
21h of anomia therapy
Participants' typical daily routine
Outcomes
Primary Outcome Measures
Speeded anomia therapy effect in reaction time
Change in reaction time in single-item picture naming
Speeded anomia therapy effect in accuracy
Change in accuracy in single-item picture naming
Generalisation to connected speech
Change in word retrieval in composite picture description. Participants will be asked to describe composite pictures (from the "Where's Waldo/Wally?" publications).
Secondary Outcome Measures
Generalisation to story-telling connected speech
Change in narrative speech production. Participants will be asked to narrate the Cinderella story. A checklist with some of the most frequently used nouns (data obtained from AphasiaBank database) will be used.
Full Information
NCT ID
NCT05512884
First Posted
August 17, 2022
Last Updated
January 16, 2023
Sponsor
University of Cambridge
Collaborators
Cambridge University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05512884
Brief Title
Speeded Anomia Treatment in Chronic Post-stroke Aphasia
Official Title
Testing the Effect of Speeded Anomia Therapy in Patients With Chronic Post-stroke Aphasia: a Cross-over Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cambridge
Collaborators
Cambridge University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main aim of the study is to investigate the effect of a novel, speeded anomia therapy (Conroy et al., 2018) in a large population of patients with chronic post-stroke aphasia. The treatment will be delivered via a web application (QuickWord).
Detailed Description
The main aim is to test the clinical efficacy of a novel, web based, rehabilitation approach to aphasic word-finding difficulties (QuickWord). In an initial development and case-series evaluation, Conroy et al (2018, Brain) found that training for both speed as well as accuracy of naming generated much better outcomes to picture naming accuracy and also augmented the carry-over to connected speech production.
This is a randomised, crossover, clinical trial of QuickWord in a group of aphasic patients in the chronic post-stroke period. The comparison will be standard care. The main outcome measures are clinically relevant improvement in naming to confrontation, and spontaneous use of the target vocabulary in a connected speech sample (detailed picture description). Secondary outcome includes measured use of the vocabulary in a story-telling, connected speech assessment (retelling of the Cinderella story).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Anomia, Speech Disorders, Language Disorders, Communication Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Speeded anomia therapy
Arm Type
Experimental
Arm Description
21h of anomia therapy
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Participants' typical daily routine
Intervention Type
Behavioral
Intervention Name(s)
Speeded anomia therapy
Intervention Description
The speeded anomia therapy was introduced as RISP (Repeated, Increasingly Speeded Production) by Conroy et al. (2018). Participants are asked to name the picture presented to them before an auditory stimulus ('beep' sound) at the end of item presentation. In each session the allotted response time is gradually reduced. After an incorrect response, participants are asked to repeat the word three times.
Primary Outcome Measure Information:
Title
Speeded anomia therapy effect in reaction time
Description
Change in reaction time in single-item picture naming
Time Frame
Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
Title
Speeded anomia therapy effect in accuracy
Description
Change in accuracy in single-item picture naming
Time Frame
Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
Title
Generalisation to connected speech
Description
Change in word retrieval in composite picture description. Participants will be asked to describe composite pictures (from the "Where's Waldo/Wally?" publications).
Time Frame
Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
Secondary Outcome Measure Information:
Title
Generalisation to story-telling connected speech
Description
Change in narrative speech production. Participants will be asked to narrate the Cinderella story. A checklist with some of the most frequently used nouns (data obtained from AphasiaBank database) will be used.
Time Frame
Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Native English speakers
Age 18 years or above
Stroke (any type) greater than 12 months post onset
No history of neurological disorders / psychiatric disorders
Normal or corrected-to-normal hearing & vision
Able to give informed consent
Currently not receiving Speech & Language therapy
Minimal repetition skills (>40% on an immediate word repetition test)
Evidence of naming difficulties (<90% in Boston Naming Test - Goodglass et al., 1983)
Exclusion Criteria:
Non-native English speakers
Less than 18 years old
Stroke less than 12 months post onset
History of neurological disorders / psychiatric disorders
Uncorrected hearing & vision
Unable to give informed consent
Currently receiving Speech & Language therapy
Insufficient repetition skills (<40% on an immediate word repetition test)
Good naming performance (>90% in Boston Naming Test - Goodglass et al., 1983)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleni Zevgolatakou, MSc
Phone
+447724386296
Email
Elena.Zevgolatakou@mrc-cbu.cam.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ajay Halai, PhD
Phone
+447508764348
Email
Ajay.Halai@mrc-cbu.cam.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Lambon Ralph, DPhil
Organizational Affiliation
MRC Cognition and Brain Sciences Unit, University of Cambridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
MRC Cognition & Brain Sciences Unit
City
Cambridge
ZIP/Postal Code
CB2 7EF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Zevgolatakou, MSc
Phone
07724386296
Email
elena.zevgolatakou@mrc-cbu.cam.ac.uk
12. IPD Sharing Statement
Citations:
PubMed Identifier
29672757
Citation
Conroy P, Sotiropoulou Drosopoulou C, Humphreys GF, Halai AD, Lambon Ralph MA. Time for a quick word? The striking benefits of training speed and accuracy of word retrieval in post-stroke aphasia. Brain. 2018 Jun 1;141(6):1815-1827. doi: 10.1093/brain/awy087.
Results Reference
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Speeded Anomia Treatment in Chronic Post-stroke Aphasia
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