NCT04260815

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
Last Updated

February 11, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 29, 2020

Last Update Submit

February 7, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in word total

    total number of words in a language sample

    pre-intervention and immediately after the intervention

  • Change in verb total

    total number of verbs in a language sample

    pre-intervention and immediately after the intervention

  • Change in utterance total

    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

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

    pre-intervention and immediately after the intervention

Secondary Outcomes (3)

  • Hospital Anxiety and Depression Scale (HADS)

    7 days

  • EPIC Physical Activity Questionnaire (EPAQ2)

    12 months

  • The Keele Assessment of Participation (KAP)

    4 weeks

Study Arms (3)

anodal tDCS on the left inferior frontal gyrus (IFG)

EXPERIMENTAL
Device: Transcranial direct-current stimulation (tDCS)

anodal tDCS on the right IFG

EXPERIMENTAL
Device: Transcranial direct-current stimulation (tDCS)

sham tDCS

SHAM COMPARATOR
Device: Transcranial direct-current stimulation (tDCS)

Interventions

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.

anodal tDCS on the left inferior frontal gyrus (IFG)anodal tDCS on the right IFGsham tDCS

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 1UL, United Kingdom

Location

Related Publications (9)

  • 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.

    PMID: 10990547BACKGROUND
  • 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.

    PMID: 29213226BACKGROUND
  • 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.

    PMID: 21477637BACKGROUND
  • 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.

    PMID: 2804622BACKGROUND
  • 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.

    PMID: 23138766BACKGROUND
  • 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.

    PMID: 8487525BACKGROUND
  • 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.

    PMID: 16155776BACKGROUND
  • 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.

    PMID: 6880820BACKGROUND
  • 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.

    PMID: 11914316BACKGROUND

MeSH Terms

Conditions

Language DisordersAphasiaStroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpeech DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 7, 2020

Study Start

October 2, 2018

Primary Completion

December 19, 2018

Study Completion

August 22, 2019

Last Updated

February 11, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

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.

Locations