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

Sponsor
King's College London (Other)
Overall Status
Completed
CT.gov ID
NCT04260815
Collaborator
(none)
14
1
3
10.6
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial direct-current stimulation (tDCS)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Transcranial Direct-current Stimulation on Discourse Production in Healthy Older Adults
Actual Study Start Date :
Oct 2, 2018
Actual Primary Completion Date :
Dec 19, 2018
Actual Study Completion Date :
Aug 22, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in word total [pre-intervention and immediately after the intervention]

    total number of words in a language sample

  2. Change in verb total [pre-intervention and immediately after the intervention]

    total number of verbs in a language sample

  3. Change in utterance total [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 [pre-intervention and immediately after the intervention]

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

Secondary Outcome Measures

  1. Hospital Anxiety and Depression Scale (HADS) [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) [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) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 King's College London London United Kingdom SE1 1UL

Sponsors and Collaborators

  • King's College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
King's College London
ClinicalTrials.gov Identifier:
NCT04260815
Other Study ID Numbers:
  • HR-19/20-6391
First Posted:
Feb 7, 2020
Last Update Posted:
Feb 11, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2020