The Effect of Non-invasive Brain Stimulation on Language Production in Post-stroke Aphasia

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204356
• Other study ID #: HR-19/20-12921
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: November 5, 2020

Study information

• Verified date: February 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 5, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Aphasia
• Language Disorders
• Stroke

Intervention

Behavioral:
• Language treatment for improving discourse production
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.

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (18)

Baker 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. — View Citation

Brady MC, Kelly H, Godwin J, Enderby P, Campbell P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2016 Jun 1;(6):CD000425. doi: 10.1002/14651858.CD000425.pub4. Review. — View Citation

Brady 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. Review. Update in: Cochrane Database Syst Rev. 2016;(6):CD000425. — View Citation

Carroll 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. — View Citation

Chiti 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. Review. — View Citation

Coelho CA, Liles BZ, Duffy RJ. Contextual influences on narrative discourse in normal young adults. J Psycholinguist Res. 1990 Nov;19(6):405-20. — View Citation

Elsner 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. Review. Update in: Cochrane Database Syst Rev. 2019 May 21;5:CD009760. — View Citation

Holland 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. — View Citation

Kang 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. — View Citation

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. — View Citation

Lomas 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. — View Citation

Marangolo 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. — View Citation

Marangolo 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. — View Citation

Monti 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. Review. — View Citation

Newton 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. — View Citation

Ross 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. — View Citation

Swinburn K. Aphasia Impact Questionnaire. Connect Commun Disabil Netw. 2015. http://www.ukconnect.org/professionals/aiq.

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verb token total	The number of all verb occurrences in a language sample	30 minutes
Primary	Verb type total	The number of distinct verbs in a sample	30 minutes
Secondary	Total number of words	The total number of words in a language sample	30 minutes
Secondary	Total number of utterances	The total number of utterances in a language sample	30 minutes
Secondary	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	30 minutes
Secondary	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	10 minutes
Secondary	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.	15 minutes
Secondary	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.	10 minutes
Secondary	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.	15 minutes