The Effect of Non-invasive Brain Stimulation on Language Production in Post-stroke Aphasia
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
1 other identifier
interventional
6
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2019
CompletedFirst Submitted
Initial submission to the registry
December 13, 2019
CompletedFirst Posted
Study publicly available on registry
December 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2020
CompletedFebruary 18, 2021
February 1, 2021
9 months
December 13, 2019
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Verb token total
The number of all verb occurrences in a language sample
30 minutes
Verb type total
The number of distinct verbs in a sample
30 minutes
Secondary Outcomes (7)
Total number of words
30 minutes
Total number of utterances
30 minutes
Predicate argument structure (PAS)
30 minutes
Communicative Effectiveness Index (CETI)
10 minutes
Aphasia Impact Questionnaire-21 (AIQ)
15 minutes
- +2 more secondary outcomes
Study Arms (2)
tDCS group
EXPERIMENTALParticipants 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 COMPARATORParticipants 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)
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King's College London
London, SE1 1UL, United Kingdom
Related Publications (18)
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.
PMID: 20077315BACKGROUNDCoelho 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.
PMID: 2286935BACKGROUNDBrady 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.
PMID: 22592672BACKGROUNDHolland 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.
PMID: 21820308BACKGROUNDMarangolo 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.
PMID: 24046740BACKGROUNDMonti 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.
PMID: 23138766BACKGROUNDBaker 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.
PMID: 20395612BACKGROUNDCarroll 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.
PMID: 29192805BACKGROUNDMarangolo 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.
PMID: 24333381BACKGROUNDBrady 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.
PMID: 27245310BACKGROUNDElsner 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.
PMID: 25929694BACKGROUNDNewton 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
BACKGROUNDPritchard 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.
PMID: 30155970BACKGROUNDLomas 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.
PMID: 2464719BACKGROUNDSwinburn K. Aphasia Impact Questionnaire. Connect Commun Disabil Netw. 2015. http://www.ukconnect.org/professionals/aiq.
BACKGROUNDChiti G, Pantoni L. Use of Montreal Cognitive Assessment in patients with stroke. Stroke. 2014 Oct;45(10):3135-40. doi: 10.1161/STROKEAHA.114.004590. Epub 2014 Aug 12. No abstract available.
PMID: 25116881BACKGROUNDKang EK, Kim YK, Sohn HM, Cohen LG, Paik NJ. Improved picture naming in aphasia patients treated with cathodal tDCS to inhibit the right Broca's homologue area. Restor Neurol Neurosci. 2011;29(3):141-52. doi: 10.3233/RNN-2011-0587.
PMID: 21586821BACKGROUNDRoss LA, McCoy D, Wolk DA, Coslett HB, Olson IR. Improved proper name recall by electrical stimulation of the anterior temporal lobes. Neuropsychologia. 2010 Oct;48(12):3671-4. doi: 10.1016/j.neuropsychologia.2010.07.024. Epub 2010 Jul 24.
PMID: 20659489BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2019
First Posted
December 18, 2019
Study Start
November 25, 2019
Primary Completion
August 28, 2020
Study Completion
November 5, 2020
Last Updated
February 18, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
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.