AphasiaNCT04204356
The Effect of Non-invasive Brain Stimulation on Language Production in Post-stroke Aphasia
A study testing Language treatment for improving discourse production and Transcranial direct-current stimulation (tDCS) in people with Aphasia and Stroke, run by King's College London at 1 site in United Kingdom.
Trial summary
Aphasia is a language impairment caused by brain injury such as stroke that affects the ability to understand and express language, read and write due to damage in the language regions of the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Stroke, Language Disorders
- What is being tested?
- Language treatment for improving discourse production and Transcranial direct-current stimulation (tDCS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2019to 5 Nov 2020
- 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
- aphasia caused by a single stroke
- at least 6 months post stroke
- at least 18 years old
- competent English speaker prior to stroke
- right handed prior to stroke
- normal aided or unaided visual acuity
- willing to participate and to comply with the proposed block of intervention and testing regime.
Who cannot join
- Persons with
- neurological symptoms or history of a neurological event other than their stroke
- contraindications to tDCS including history of epilepsy or seizures and pacemakers
- global/severe aphasia
- cognitive impairment identified by a score less than 20/30 in the Montreal Cognitive Assessment
- left-handed dominance prior to stroke
- visual problems which interfere with persons' ability to access visual materials (i.e. pictures)
- inability to attend sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Speech and Language Therapy With and Without Transcranial Direct-current Stimulation on Discourse Production in People With Post-stroke Aphasia: a Pilot Randomised Controlled Trial
Aphasia is a language impairment caused by brain injury such as stroke that affects the ability to understand and express language, read and write due to damage in the language regions of the brain. Non-invasive brain stimulation (NIBS) techniques like transcranial direct-current stimulation (tDCS) have been found to improve aphasia treatment effects in post stroke patient populations such as improved naming abilities.
However, the effect of tDCS on more functional, higher level language skills such as discourse production (i.e. story telling, giving instructions) has yet to be understood.Therefore the aim of this study is to determine the potential effectiveness of tDCS as an adjunct to speech and language therapy (SLT) to improve discourse speech production in people with post-stroke aphasia. It is hypothesised that SLT combined with tDCS will result in greater improvements in discourse language production compared to SLT on its own.
- Conditions
- Aphasia, Stroke, Language Disorders
- Being tested
- Language treatment for improving discourse production, Transcranial direct-current stimulation (tDCS)
- Medical subject headings
- Aphasia, Stroke, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language treatment for improving discourse productionBehavioural
All participants will receive a 6-week block of language treatment for improving verb retrieval in discourse production by a professional speech and language therapist. The treatment goals for this block of treatment are to 1) improve verb retrieval and language quantity and complexity in discourse production 2) improve functional communication skills and; 3) improve quality of life and psychological state in people with post-stroke chronic aphasia.
Transcranial direct-current stimulation (tDCS)Device
Transcranial direct-current stimulation is a non-invasive brain stimulation method that can modify spontaneous cortical activity in targeted brain regions. Anodal tDCS delivered through a positively charged electrode has been found to increase cortical excitability in a targeted brain region. The use of tDCS as an adjunct to speech and language therapy has been found to improve aphasia treatment effects in post stroke patient populations.
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Experimental | Participants randomly allocated to this group using a random number generator will receive a once weekly, 6-week block of language treatment with active tDCS. Receives: Behavioral: Language treatment for improving discourse production; Device: Transcranial direct-current stimulation (tDCS) |
| Sham group | Sham comparator | Participants randomly allocated to this group using a random number generator will receive a once weekly, 6-week block of language treatment without active tDCS (sham) Receives: Behavioral: Language treatment for improving discourse production |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verb token total
The number of all verb occurrences in a language sample
Measured: 30 minutes
Verb type total
The number of distinct verbs in a sample
Measured: 30 minutes
Secondary outcomes (7)
Total number of words
The total number of words in a language sample
Measured: 30 minutes
Total number of utterances
The total number of utterances in a language sample
Measured: 30 minutes
Predicate argument structure (PAS)
The main verbs and their arguments will be identified in each sentence within a language sample. A PAS complexity score will be calculated using the formula: number of arguments/number of main verbs
Measured: 30 minutes
Communicative Effectiveness Index (CETI)
CETI is a valid and reliable measure of change in functional communication ability in adults with aphasia. This assessment includes 16 everyday situations such as having a one to one conversation and giving yes or no answers appropriately. Participants are asked to rate their ability in each particular communication situation using a rating scale with one end labelled as 'not at all able and the other 'as able as before
Measured: 10 minutes
Aphasia Impact Questionnaire-21 (AIQ)
AIQ is a self-report questionnaire which utilises pictures to enable people with aphasia to communicate their experiences of aphasia. There are 8 questionnaires to select from with scales that vary in relation to gender and race. Pictorial responses can be translated into numerical scores, and then documented on a summary score sheet. The questionnaire has three sections; communication, participation and well-being/emotional state. The first section looks at activities which are commonly difficult for people with aphasia such as talking and understanding. The participation section looks at how communication difficulties arising from aphasia impact the person's ability to complete tasks in everyday life such as shopping and work. The last section looks at the emotional effect of aphasia.
Measured: 15 minutes
Hospital Anxiety and Depression Scale (HADS)
HADS is a 14-item scale which assesses non-somatic anxiety and depression symptoms. Scores range from 0 to 21 for each sub-scale with a score ≥8 proposed for the identification of caseness, for both depression and anxiety.
Measured: 10 minutes
Montreal Cognitive Assessment (MoCA)
The MoCA is a brief and easy to administer cognitive assessment. Different aspects of cognition such as memory, executive function, language, visual-spatial ability and orientation are assessed. Scores range from 0-30, where the recommended cut-off score for identifying multi-domain cognitive impairment in persons with chronic stroke is 20/30.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start25 Nov 2019
- Primary completion28 Aug 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by King's 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204356
- Sponsor's protocol ID
- HR-19/20-12921
- Status last verified
- Feb 2021
- First submitted
- 13 Dec 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information collected will be kept confidential and stored anonymously on password protected computers used only by research staff who are part of the study. Data will be stored securely in accordance with the Data Protection Act (1998) and the General Data Protection Regulations (May 2018). Stored, anonymised data may be used for future medical and health-related studies. Anonymised data will be retained for 10 years.
Publications
Lambon Ralph MA, Snell C, Fillingham JK, Conroy P, Sage K. Predicting the outcome of anomia therapy for people with aphasia post CVA: both language and cognitive status are key predictors. Neuropsychol Rehabil. 2010 Apr;20(2):289-305. doi: 10.1080/09602010903237875. Epub 2010 Jan 1.
PubMed 20077315Coelho CA, Liles BZ, Duffy RJ. Contextual influences on narrative discourse in normal young adults. J Psycholinguist Res. 1990 Nov;19(6):405-20. doi: 10.1007/BF01068887.
PubMed 2286935Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.
PubMed 22592672Holland R, Leff AP, Josephs O, Galea JM, Desikan M, Price CJ, Rothwell JC, Crinion J. Speech facilitation by left inferior frontal cortex stimulation. Curr Biol. 2011 Aug 23;21(16):1403-7. doi: 10.1016/j.cub.2011.07.021. Epub 2011 Aug 4.
PubMed 21820308Marangolo P, Fiori V, Calpagnano MA, Campana S, Razzano C, Caltagirone C, Marini A. tDCS over the left inferior frontal cortex improves speech production in aphasia. Front Hum Neurosci. 2013 Sep 6;7:539. doi: 10.3389/fnhum.2013.00539. eCollection 2013.
PubMed 24046740Monti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. Transcranial direct current stimulation (tDCS) and language. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):832-42. doi: 10.1136/jnnp-2012-302825. Epub 2012 Nov 8.
PubMed 23138766Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.
PubMed 20395612Carroll C, Guinan N, Kinneen L, Mulheir D, Loughnane H, Joyce O, Higgins E, Boyle E, Mullarney M, Lyons R. Social participation for people with communication disability in coffee shops and restaurants is a human right. Int J Speech Lang Pathol. 2018 Feb;20(1):59-62. doi: 10.1080/17549507.2018.1397748. Epub 2017 Dec 1.
PubMed 29192805Marangolo P, Fiori V, Campana S, Calpagnano MA, Razzano C, Caltagirone C, Marini A. Something to talk about: enhancement of linguistic cohesion through tdCS in chronic non fluent aphasia. Neuropsychologia. 2014 Jan;53:246-56. doi: 10.1016/j.neuropsychologia.2013.12.003. Epub 2013 Dec 11.
PubMed 24333381Brady MC, Kelly H, Godwin J, Enderby P, Campbell P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2016 Jun 1;2016(6):CD000425. doi: 10.1002/14651858.CD000425.pub4.
PubMed 27245310Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. Cochrane Database Syst Rev. 2015 May 1;(5):CD009760. doi: 10.1002/14651858.CD009760.pub3.
PubMed 25929694Newton C, Kirby P, Bruce C. Getting into shape: the effect of Shape Coding on the spoken language production of two men with chronic aphasia. Aphasiology. 2017;31(12):1459-1481. doi:10.1080/02687038.2017.1306639
Pritchard M, Hilari K, Cocks N, Dipper L. Psychometric properties of discourse measures in aphasia: acceptability, reliability, and validity. Int J Lang Commun Disord. 2018 Nov;53(6):1078-1093. doi: 10.1111/1460-6984.12420. Epub 2018 Aug 28.
PubMed 30155970Lomas J, Pickard L, Bester S, Elbard H, Finlayson A, Zoghaib C. The communicative effectiveness index: development and psychometric evaluation of a functional communication measure for adult aphasia. J Speech Hear Disord. 1989 Feb;54(1):113-24. doi: 10.1044/jshd.5401.113.
PubMed 2464719Swinburn K. Aphasia Impact Questionnaire. Connect Commun Disabil Netw. 2015. http://www.ukconnect.org/professionals/aiq.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Speech and Language Therapy With and Without Transcranial Direct-current Stimulation on Discourse Production in People With Post-stroke Aphasia: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04204356
- Acronym / sponsor ID
- HR-19/20-12921
- Conditions
- Aphasia, Stroke, Language Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 18 Dec 2019 (actual)
- 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.
Aphasia is a language impairment caused by brain injury such as stroke that affects the ability to understand and express language, read and write due to damage in the language regions of the brain. Non-invasive brain stimulation (NIBS) techniques like transcranial direct-current stimulation (tDCS) have been found to improve aphasia treatment effects in post stroke patient populations such as improved naming abilities.
However, the effect of tDCS on more functional, higher level language skills such as discourse production (i.e. story telling, giving instructions) has yet to be understood.Therefore the aim of this study is to determine the potential effectiveness of tDCS as an adjunct to speech and language therapy (SLT) to improve discourse speech production in people with post-stroke aphasia. It is hypothesised that SLT combined with tDCS will result in greater improvements in discourse language production compared to SLT on its own.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Experimental | Behavioral: Language treatment for improving discourse production, Device: Transcranial direct-current stimulation (tDCS)Participants randomly allocated to this group using a random number generator will receive a once weekly, 6-week block of language treatment with active tDCS. |
| Sham group | Sham comparator | Behavioral: Language treatment for improving discourse productionParticipants randomly allocated to this group using a random number generator will receive a once weekly, 6-week block of language treatment without active tDCS (sham) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aphasia caused by a single stroke
- at least 6 months post stroke
- at least 18 years old
- competent English speaker prior to stroke
- right handed prior to stroke
Key exclusion criteria (8 listed)
- Persons with
- neurological symptoms or history of a neurological event other than their stroke
- contraindications to tDCS including history of epilepsy or seizures and pacemakers
- global/severe aphasia
- cognitive impairment identified by a score less than 20/30 in the Montreal Cognitive Assessment
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 |
|---|---|---|
| Language treatment for improving discourse productionAll participants will receive a 6-week block of language treatment for improving verb retrieval in discourse production by a professional speech and language therapist. The treatment goals for this block of treatment are to 1) improve verb retrieval and language quantity and complexity in discourse production 2) improve functional communication skills and; 3) improve quality of life and psychological state in people with post-stroke chronic aphasia. | Behavioural | Sham group, tDCS group |
| Transcranial direct-current stimulation (tDCS)Transcranial direct-current stimulation is a non-invasive brain stimulation method that can modify spontaneous cortical activity in targeted brain regions. Anodal tDCS delivered through a positively charged electrode has been found to increase cortical excitability in a targeted brain region. The use of tDCS as an adjunct to speech and language therapy has been found to improve aphasia treatment effects in post stroke patient populations. | Device | tDCS group |
Primary outcome
Verb token total
Time frame: 30 minutes
The number of all verb occurrences in a language sample
Verb type total
Time frame: 30 minutes
The number of distinct verbs in a sample
7 secondary outcomes
Total number of words
Time frame: 30 minutes
Total number of utterances
Time frame: 30 minutes
Predicate argument structure (PAS)
Time frame: 30 minutes
Communicative Effectiveness Index (CETI)
Time frame: 10 minutes
Aphasia Impact Questionnaire-21 (AIQ)
Time frame: 15 minutes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 10 minutes
Montreal Cognitive Assessment (MoCA)
Time frame: 15 minutes
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 18 Feb 2021.
- Background: PubMed 20077315Lambon Ralph MA, Snell C, Fillingham JK, Conroy P, Sage K. Predicting the outcome of anomia therapy for people with aphasia post CVA: both language and cognitive status are key predictors. Neuropsychol Rehabil. 2010 Apr;20(2):289-305. doi: 10.1080/09602010903237875. Epub 2010 Jan 1.
- Background: PubMed 2286935Coelho CA, Liles BZ, Duffy RJ. Contextual influences on narrative discourse in normal young adults. J Psycholinguist Res. 1990 Nov;19(6):405-20. doi: 10.1007/BF01068887.
- Background: PubMed 22592672Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.
- Background: PubMed 21820308Holland R, Leff AP, Josephs O, Galea JM, Desikan M, Price CJ, Rothwell JC, Crinion J. Speech facilitation by left inferior frontal cortex stimulation. Curr Biol. 2011 Aug 23;21(16):1403-7. doi: 10.1016/j.cub.2011.07.021. Epub 2011 Aug 4.
- Background: PubMed 24046740Marangolo P, Fiori V, Calpagnano MA, Campana S, Razzano C, Caltagirone C, Marini A. tDCS over the left inferior frontal cortex improves speech production in aphasia. Front Hum Neurosci. 2013 Sep 6;7:539. doi: 10.3389/fnhum.2013.00539. eCollection 2013.
- Background: PubMed 23138766Monti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. Transcranial direct current stimulation (tDCS) and language. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):832-42. doi: 10.1136/jnnp-2012-302825. Epub 2012 Nov 8.
- Background: PubMed 20395612Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.
- Background: PubMed 29192805Carroll C, Guinan N, Kinneen L, Mulheir D, Loughnane H, Joyce O, Higgins E, Boyle E, Mullarney M, Lyons R. Social participation for people with communication disability in coffee shops and restaurants is a human right. Int J Speech Lang Pathol. 2018 Feb;20(1):59-62. doi: 10.1080/17549507.2018.1397748. Epub 2017 Dec 1.
- Background: PubMed 24333381Marangolo P, Fiori V, Campana S, Calpagnano MA, Razzano C, Caltagirone C, Marini A. Something to talk about: enhancement of linguistic cohesion through tdCS in chronic non fluent aphasia. Neuropsychologia. 2014 Jan;53:246-56. doi: 10.1016/j.neuropsychologia.2013.12.003. Epub 2013 Dec 11.
- Background: PubMed 27245310Brady MC, Kelly H, Godwin J, Enderby P, Campbell P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2016 Jun 1;2016(6):CD000425. doi: 10.1002/14651858.CD000425.pub4.
- Background: PubMed 25929694Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. Cochrane Database Syst Rev. 2015 May 1;(5):CD009760. doi: 10.1002/14651858.CD009760.pub3.
- BackgroundNewton C, Kirby P, Bruce C. Getting into shape: the effect of Shape Coding on the spoken language production of two men with chronic aphasia. Aphasiology. 2017;31(12):1459-1481. doi:10.1080/02687038.2017.1306639
- Individual participant dataSharing planned: No. All information collected will be kept confidential and stored anonymously on password protected computers used only by research staff who are part of the study. Data will be stored securely in accordance with the Data Protection Act (1998) and the General Data Protection Regulations (May 2018). Stored, anonymised data may be used for future medical and health-related studies. Anonymised data will be retained for 10 years.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language treatment for improving discourse production and Transcranial direct-current stimulation (tDCS) in people with Aphasia and Stroke, run by King's 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 7 inclusion and 8 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 18 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
Verb token total (time frame: 30 minutes). 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?
On the ClinicalTrials.gov record for NCT04204356, which also lists 18 linked publications.
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 18 Feb 2021.