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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

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Anomia, Speech Disorders, Language Disorders, Communication Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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

Elena.Zevgolatakou@mrc-cbu.cam.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Ajay Halai, PhD

Phone

+447508764348

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

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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