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

February 7, 2020 updated by: King's College London

The Effect of Transcranial Direct-current Stimulation on Discourse 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: sham tDCS
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. Application of tDCS has been found to improve language production in healthy and brain-injured speakers.
Experimental: anodal tDCS on the left inferior frontal gyrus (IFG)
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. Application of tDCS has been found to improve language production in healthy and brain-injured speakers.
Experimental: anodal tDCS on the right IFG
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. Application of tDCS has been found to improve language production in healthy and brain-injured speakers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in word total
Time Frame: pre-intervention and immediately after the intervention
total number of words in a language sample
pre-intervention and immediately after the intervention
Change in verb total
Time Frame: pre-intervention and immediately after the intervention
total number of verbs in a language sample
pre-intervention and immediately after the intervention
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
pre-intervention and immediately after the intervention
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
pre-intervention and immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days
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'.
12 months
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).
4 weeks

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)

October 2, 2018

Primary Completion (Actual)

December 19, 2018

Study Completion (Actual)

August 22, 2019

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-19/20-6391

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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