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Language DisordersNCT04260815

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

A study testing Transcranial direct-current stimulation (tDCS) in people with Language Disorders and Aphasia, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Language Disorders, Aphasia, Stroke
What is being tested?
Transcranial direct-current stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteUnited Kingdom
Study dates
2 Oct 2018to 22 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • King's College London

    London, SE1 1UL

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Transcranial direct-current stimulation (tDCS)
Medical subject headings
Language Disorders, Aphasia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04260815
Study groupRoleWhat they receive
anodal tDCS on the left inferior frontal gyrus (IFG)ExperimentalNot described
Receives: Device: Transcranial direct-current stimulation (tDCS)
anodal tDCS on the right IFGExperimentalNot described
Receives: Device: Transcranial direct-current stimulation (tDCS)
sham tDCSSham comparatorNot described
Receives: Device: Transcranial direct-current stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in word total

    total number of words in a language sample

    Measured: pre-intervention and immediately after the intervention

  2. Change in verb total

    total number of verbs in a language sample

    Measured: pre-intervention and immediately after the intervention

  3. Change in utterance total

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

    Measured: pre-intervention and immediately after the intervention

  4. Change in percent of Correct Information Units

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

    Measured: pre-intervention and immediately after the intervention

Secondary outcomes (3)

  1. Hospital Anxiety and Depression Scale (HADS)

    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.

    Measured: 7 days

  2. EPIC Physical Activity Questionnaire (EPAQ2)

    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'.

    Measured: 12 months

  3. The Keele Assessment of Participation (KAP)

    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).

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start2 Oct 2018
  3. Primary completion19 Dec 2018
  4. Study completion22 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04260815
Sponsor's protocol ID
HR-19/20-6391
Status last verified
Jan 2020
First submitted
29 Jan 2020
Last updated
11 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

    PubMed 10990547

  • Thair H, Holloway AL, Newport R, Smith AD. Transcranial Direct Current Stimulation (tDCS): A Beginner's Guide for Design and Implementation. Front Neurosci. 2017 Nov 22;11:641. doi: 10.3389/fnins.2017.00641. eCollection 2017.

    PubMed 29213226

  • Cattaneo Z, Pisoni A, Papagno C. Transcranial direct current stimulation over Broca's region improves phonemic and semantic fluency in healthy individuals. Neuroscience. 2011 Jun 2;183:64-70. doi: 10.1016/j.neuroscience.2011.03.058. Epub 2011 Apr 6.

    PubMed 21477637

  • Saffran EM, Berndt RS, Schwartz MF. The quantitative analysis of agrammatic production: procedure and data. Brain Lang. 1989 Oct;37(3):440-79. doi: 10.1016/0093-934x(89)90030-8.

    PubMed 2804622

  • 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.

    PubMed 23138766

  • Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.

    PubMed 8487525

  • Wilkie R, Peat G, Thomas E, Hooper H, Croft PR. The Keele Assessment of Participation: a new instrument to measure participation restriction in population studies. Combined qualitative and quantitative examination of its psychometric properties. Qual Life Res. 2005 Oct;14(8):1889-99. doi: 10.1007/s11136-005-4325-2.

    PubMed 16155776

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Wareham NJ, Jakes RW, Rennie KL, Mitchell J, Hennings S, Day NE. Validity and repeatability of the EPIC-Norfolk Physical Activity Questionnaire. Int J Epidemiol. 2002 Feb;31(1):168-74. doi: 10.1093/ije/31.1.168.

    PubMed 11914316

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct-current stimulation (tDCS) in people with Language Disorders and Aphasia, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in word total (time frame: pre-intervention and immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04260815, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

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