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Completed

NCT Number: NCT04260815

The Effect of Non-invasive Brian Stimulation on Language Production in Healthy Older Adults

The use of non-invasive brain stimulation techniques like transcranial direct-current stimulation (tDCS) for rehabilitation of language is a growing field that needs further studies to determine how best it can be used to enhance treatment outcomes. It has been shown that tDCS can improve language performance in healthy and brain-injured individuals such as increased naming accuracy.

However, at present, it is not known what effect tDCS has on higher-level language skills like discourse production (i.e. story telling, giving instructions) in healthy, older speakers. Therefore, the aim of this study is to investigate in healthy older adults, the effect of tDCS on discourse production as well as the ideal tDCS electrode placement for improving language at the discourse level. It is hypothesised that tDCS will result in greater language changes and improvements during discourse production compared to no stimulation.

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Key information

Conditions

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

Age range

65 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: Yes

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

Inclusion criteria

  • At least 65 years of age
  • Native English speakers
  • Right handed
  • Normal aided or unaided visual acuity
  • At least secondary school level of education

Exclusion criteria

  • History of neurological disease or cognitive impairment
  • Any contraindication of tDCS (i.e. history of seizures, metal implants)

Treatment and study plan

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. Application of tDCS has been found to improve language production in healthy and brain-injured speakers.

Primary outcomes

  1. Change in word total

    Time frame: pre-intervention and immediately after the intervention

    total number of words in a language sample

  2. Change in verb total

    Time frame: pre-intervention and immediately after the intervention

    total number of verbs in a language sample

  3. Change in utterance total

    Time frame: pre-intervention and immediately after the intervention

    total number of utterances (complete sentences including a predicate and argument) in a language sample

  4. Change in percent of Correct Information Units

    Time frame: pre-intervention and immediately after the intervention

    The percent of accurately produced words that provide information relevant to the language task

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 7 days

    HADS is a 14-item scale which assesses non-somatic anxiety and depression symptoms experienced in the past week. 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.

  2. EPIC Physical Activity Questionnaire (EPAQ2)

    Time frame: 12 months

    The EPAQ2 is a self completed questionnaire which collects information on a person's physical activity levels at home, work and recreation. Based on total activity hours in the last 12 months, the physical activity index categorises levels of physical activity into 'active', 'moderately inactive', 'moderately active' or 'active'.

  3. The Keele Assessment of Participation (KAP)

    Time frame: 4 weeks

    The KAP is a short questionnaire that measures participation levels in various activities such as activities of daily living, social activities and work in the last 4 weeks. A score of 0 indicates no restriction in participation whereas scores from 1-11 indicate a restriction in participation in at least one activity ( the higher the score the greater the restriction).

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

The Effect of Transcranial Direct-current Stimulation on Discourse Production in Healthy Older Adults

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 7, 2020
Registry last updated
Feb 11, 2020

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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