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Completed

NCT Number: NCT04204356

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

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.

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Key information

Conditions

Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, SE1 1UL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Language treatment for improving discourse production

Behavioral

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.

Primary outcomes

  1. Verb token total

    Time frame: 30 minutes

    The number of all verb occurrences in a language sample

  2. Verb type total

    Time frame: 30 minutes

    The number of distinct verbs in a sample

Secondary outcomes

  1. Total number of words

    Time frame: 30 minutes

    The total number of words in a language sample

  2. Total number of utterances

    Time frame: 30 minutes

    The total number of utterances in a language sample

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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