StrokeNCT02545894
An Evaluation of a New Nonverbal Treatment for Global Aphasia
A study testing Cognitive therapy in people with Stroke, run by University College, London at 1 site in United Kingdom.
Trial summary
People with global aphasia (PwGA) post stroke have little to no meaningful communication abilities (ie limited comprehension, spoken language, reading and writing abilities).A proportion of PwGA will also have limited abilities to use any alternative means of communication e.g. gesture, pictures or computer devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have global aphasia as diagnosed by an SLT
- have little or no verbal output
- inconsistent single word comprehension
- little or no ability to read or write
- little or no ability to use alternative modes of communication
- Little or no ability to make choices in function
Show all 10Show fewer
- no diagnosis/history of a progressive neurological condition
- no diagnosis of hearing loss
- no diagnosis/history of a mental health condition
- English as a first language
Who cannot join
- has another form of aphasia
- is able to consistently express basic needs non-verbally or verbally.
- is able to participate in communicative interaction with a familiar other
- has a history of a progressive neurological condition
- has hearing loss
- has a diagnosis/history of a mental health condition
- does not have English as a first language.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London, Research Dept of Language and Cognition
London, WC1N
About this study
Official title: An Investigation Into the Effect of a Novel, Non Verbal, Cognitive Treatment on Functional Communication in Global Aphasia
People with global aphasia (PwGA) post stroke have little to no meaningful communication abilities (ie limited comprehension, spoken language, reading and writing abilities).A proportion of PwGA will also have limited abilities to use any alternative means of communication e.g. gesture, pictures or computer devices. There is a suggestion in the literature that this is because of co-occurring cognitive deficits. The consequence is that these clients are unable to reliably communicate even their basic needs.This is commonly known as having no functional communication abilities. Such PwGA tend not to respond to standard speech and language therapy interventions.
This research will investigate the effect of a new cognitive intervention designed to improve basic functional communication abilities. The treatment will be nonverbal and involve computer and paperbased tasks ordered hierarchically from basic to more complex tasks. Six to eight participants will take part. All their sessions will take place in their own home. For some this may be a care home. They will first complete a diagnostic communication assessment in order for baseline abilities to be established. Further formal language and cognitive assessments will be conducted over a period of 6 weeks. A relative/friend will complete a questionnaires about mood/communication. The PwGA will also be videoed interacting with the research student e.g. looking at a magazine, completing a jigsaw, answering questions and making choices non-verbally.
The participants then receive the new intervention 3 times a week for 6 consecutive weeks. All intervention sessions will be videoed. Then participants will be reassessed over 2 weeks using the same assessments as prior to the intervention. The questionnaire with their relative/friend and videoed activity session will also be repeated. After a twelve week break the participant will be videoed interacting with the research student complete some of the assessments again and their relative will re-complete the questionnaires.
- Conditions
- Stroke
- Being tested
- Cognitive therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive therapyBehavioural
The tasks are:
- visually tracking a picture as it moves across the computer screen
- pressing a button every time a picture is seen on the screen
- pressing a button every time a specific picture is seen on the screen
- Pressing a button every time a specific sound is heard
- Matching objects to a picture
- Matching gestures to objects
- Matching two connected objects
- Sorting objects by categories
- Matching sounds to objects
- "Complete the category" and "odd on out with objects"
- Choosing target objects by pointing
- Choosing objects to complete the category by pointing
| Study group | Role | What they receive |
|---|---|---|
| BASELINE TESTING | No intervention | Language and cognitive assessments conducted |
| Treatment | Experimental | Intervention given:
visual tracking pressing a button every time a picture is seen on the screen
* playing dominoes and snap
* pressing a button every time a specific picture is seen on the screen
* Pressing a button every time a specific sound is heard
* Matching objects to a picture
* Matching gestures to objects
* Matching two connected objects
* Sorting objects by categories
* Matching sounds to objects
* "Complete the category" and "odd on out with objects"
* Choosing target objects by pointing
* Choosing objects to complete the category by pointing Receives: Behavioral: Cognitive therapy |
| Post intervention | No intervention | Repeated testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Speech and Hearing Association -Functional Assessment of Communication
Questionnaire completed by friend/relative
Measured: 27 weeks
Constructed Interaction Task
video recorded interaction
Measured: 27 weeks
Secondary outcomes (6)
Aphasia Screening Test
Language assessment
Measured: 14 weeks
Mood Screen
depression screening tool
Measured: 27 weeks
Pyramids and Palm Trees Test
pictorial semantic assessment
Measured: 27 weeks
Wisconsin Card Sorting Test
cognitive assessment
Measured: 14 weeks
Butt Non verbal reasoning test
cognitive assessment
Measured: 27 weeks
Western Aphasia Battery cognitive sub test
cognitive assessment
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Beeke, PhD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545894
- Sponsor's protocol ID
- 13/0581
- Status last verified
- Jan 2020
- First submitted
- 22 Jun 2015
- Last updated
- 29 Jan 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Effect of a Novel, Non Verbal, Cognitive Treatment on Functional Communication in Global Aphasia
- ClinicalTrials.gov ID
- NCT02545894
- Acronym / sponsor ID
- 13/0581
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with global aphasia (PwGA) post stroke have little to no meaningful communication abilities (ie limited comprehension, spoken language, reading and writing abilities).A proportion of PwGA will also have limited abilities to use any alternative means of communication e.g. gesture, pictures or computer devices. There is a suggestion in the literature that this is because of co-occurring cognitive deficits. The consequence is that these clients are unable to reliably communicate even their basic needs.This is commonly known as having no functional communication abilities. Such PwGA tend not to respond to standard speech and language therapy interventions.
This research will investigate the effect of a new cognitive intervention designed to improve basic functional communication abilities. The treatment will be nonverbal and involve computer and paperbased tasks ordered hierarchically from basic to more complex tasks. Six to eight participants will take part. All their sessions will take place in their own home. For some this may be a care home. They will first complete a diagnostic communication assessment in order for baseline abilities to be established. Further formal language and cognitive assessments will be conducted over a period of 6 weeks. A relative/friend will complete a questionnaires about mood/communication. The PwGA will also be videoed interacting with the research student e.g. looking at a magazine, completing a jigsaw, answering questions and making choices non-verbally.
The participants then receive the new intervention 3 times a week for 6 consecutive weeks. All intervention sessions will be videoed. Then participants will be reassessed over 2 weeks using the same assessments as prior to the intervention. The questionnaire with their relative/friend and videoed activity session will also be repeated. After a twelve week break the participant will be videoed interacting with the research student complete some of the assessments again and their relative will re-complete the questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BASELINE TESTING | No intervention | –Language and cognitive assessments conducted |
| Treatment | Experimental | Behavioral: Cognitive therapyIntervention given: visual tracking pressing a button every time a picture is seen on the screen * playing dominoes and snap * pressing a button every time a specific picture is seen on the screen * Pressing a button every time a specific sound is heard * Matching objects to a picture * Matching gestures to objects * Matching two connected objects * Sorting objects by categories * Matching sounds to objects * "Complete the category" and "odd on out with objects" * Choosing target objects by pointing * Choosing objects to complete the category by pointing |
| Post intervention | No intervention | –Repeated testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- have global aphasia as diagnosed by an SLT
- have little or no verbal output
- inconsistent single word comprehension
- little or no ability to read or write
- little or no ability to use alternative modes of communication
Key exclusion criteria (7 listed)
- has another form of aphasia
- is able to consistently express basic needs non-verbally or verbally.
- is able to participate in communicative interaction with a familiar other
- has a history of a progressive neurological condition
- has hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive therapyThe tasks are: * visually tracking a picture as it moves across the computer screen * pressing a button every time a picture is seen on the screen * pressing a button every time a specific picture is seen on the screen * Pressing a button every time a specific sound is heard * Matching objects to a picture * Matching gestures to objects * Matching two connected objects * Sorting objects by categories * Matching sounds to objects * "Complete the category" and "odd on out with objects" * Choosing target objects by pointing * Choosing objects to complete the category by pointing | Behavioural | Treatment |
Primary outcome
American Speech and Hearing Association -Functional Assessment of Communication
Time frame: 27 weeks
Questionnaire completed by friend/relative
Constructed Interaction Task
Time frame: 27 weeks
video recorded interaction
6 secondary outcomes
Aphasia Screening Test
Time frame: 14 weeks
Mood Screen
Time frame: 27 weeks
Pyramids and Palm Trees Test
Time frame: 27 weeks
Wisconsin Card Sorting Test
Time frame: 14 weeks
Butt Non verbal reasoning test
Time frame: 27 weeks
Western Aphasia Battery cognitive sub test
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Beeke, PhD principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive therapy in people with Stroke, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Speech and Hearing Association -Functional Assessment of Communication (time frame: 27 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.