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

February 17, 2021 updated by: King's College London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 1UL
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS group
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.
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.
Sham Comparator: Sham group
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verb token total
Time Frame: 30 minutes
The number of all verb occurrences in a language sample
30 minutes
Verb type total
Time Frame: 30 minutes
The number of distinct verbs in a sample
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of words
Time Frame: 30 minutes
The total number of words in a language sample
30 minutes
Total number of utterances
Time Frame: 30 minutes
The total number of utterances in a language sample
30 minutes
Predicate argument structure (PAS)
Time Frame: 30 minutes
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
Communicative Effectiveness Index (CETI)
Time Frame: 10 minutes
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
Aphasia Impact Questionnaire-21 (AIQ)
Time Frame: 15 minutes
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
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 10 minutes
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
Montreal Cognitive Assessment (MoCA)
Time Frame: 15 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2019

Primary Completion (Actual)

August 28, 2020

Study Completion (Actual)

November 5, 2020

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-19/20-12921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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