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

Primary Purpose

Aphasia, Stroke, Language Disorders

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Language treatment for improving discourse production
Transcranial direct-current stimulation (tDCS)
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

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

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

Sites / Locations

  • King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS group

Sham group

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

Verb token total
The number of all verb occurrences in a language sample
Verb type total
The number of distinct verbs in a sample

Secondary Outcome Measures

Total number of words
The total number of words in a language sample
Total number of utterances
The total number of utterances in a language sample
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
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
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.
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.
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.

Full Information

First Posted
December 13, 2019
Last Updated
February 17, 2021
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT04204356
Brief Title
The Effect of Non-invasive Brain Stimulation on Language Production in Post-stroke Aphasia
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke, Language Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Language treatment for improving discourse production
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct-current stimulation (tDCS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Verb token total
Description
The number of all verb occurrences in a language sample
Time Frame
30 minutes
Title
Verb type total
Description
The number of distinct verbs in a sample
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Total number of words
Description
The total number of words in a language sample
Time Frame
30 minutes
Title
Total number of utterances
Description
The total number of utterances in a language sample
Time Frame
30 minutes
Title
Predicate argument structure (PAS)
Description
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
Time Frame
30 minutes
Title
Communicative Effectiveness Index (CETI)
Description
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
Time Frame
10 minutes
Title
Aphasia Impact Questionnaire-21 (AIQ)
Description
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.
Time Frame
15 minutes
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
10 minutes
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 1UL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
20077315
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.
Results Reference
background
PubMed Identifier
2286935
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. doi: 10.1007/BF01068887.
Results Reference
background
PubMed Identifier
22592672
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.
Results Reference
background
PubMed Identifier
21820308
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.
Results Reference
background
PubMed Identifier
24046740
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.
Results Reference
background
PubMed Identifier
23138766
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.
Results Reference
background
PubMed Identifier
20395612
Citation
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.
Results Reference
background
PubMed Identifier
29192805
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.
Results Reference
background
PubMed Identifier
24333381
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.
Results Reference
background
PubMed Identifier
27245310
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;2016(6):CD000425. doi: 10.1002/14651858.CD000425.pub4.
Results Reference
background
PubMed Identifier
25929694
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
30155970
Citation
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.
Results Reference
background
PubMed Identifier
2464719
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. doi: 10.1044/jshd.5401.113.
Results Reference
background
Citation
Swinburn K. Aphasia Impact Questionnaire. Connect Commun Disabil Netw. 2015. http://www.ukconnect.org/professionals/aiq.
Results Reference
background
PubMed Identifier
25116881
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. No abstract available.
Results Reference
background
PubMed Identifier
21586821
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.
Results Reference
background
PubMed Identifier
20659489
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.
Results Reference
background

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

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