- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05512884
Speeded Anomia Treatment in Chronic Post-stroke Aphasia
Testing the Effect of Speeded Anomia Therapy in Patients With Chronic Post-stroke Aphasia: a Cross-over Randomized Controlled Trial
Study Overview
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eleni Zevgolatakou, MSc
- Phone Number: +447724386296
- Email: Elena.Zevgolatakou@mrc-cbu.cam.ac.uk
Study Contact Backup
- Name: Ajay Halai, PhD
- Phone Number: +447508764348
- Email: Ajay.Halai@mrc-cbu.cam.ac.uk
Study Locations
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Cambridge, United Kingdom, CB2 7EF
- Recruiting
- MRC Cognition & Brain Sciences Unit
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Contact:
- Eleni Zevgolatakou, MSc
- Phone Number: 07724386296
- Email: elena.zevgolatakou@mrc-cbu.cam.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Speeded anomia therapy
21h of anomia therapy
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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.
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No Intervention: Standard care
Participants' typical daily routine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speeded anomia therapy effect in reaction time
Time Frame: Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
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Change in reaction time in single-item picture naming
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Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
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Speeded anomia therapy effect in accuracy
Time Frame: Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
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Change in accuracy in single-item picture naming
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Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
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Generalisation to connected speech
Time Frame: Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
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Change in word retrieval in composite picture description.
Participants will be asked to describe composite pictures (from the "Where's Waldo/Wally?"
publications).
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Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalisation to story-telling connected speech
Time Frame: Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
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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.
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Measured over 10 weeks (Week 0, Week 2, Week 4, Week 6, Week 10)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew Lambon Ralph, DPhil, MRC Cognition and Brain Sciences Unit, University of Cambridge
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01/8/094
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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