The Effect of Non-invasive Brian Stimulation on Language Production in Healthy Older Adults
Primary Purpose
Language Disorders, Aphasia, Stroke
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transcranial direct-current stimulation (tDCS)
Sponsored by
About this trial
This is an interventional treatment trial for Language Disorders
Eligibility Criteria
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)
Sites / Locations
- King's College London
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
anodal tDCS on the left inferior frontal gyrus (IFG)
anodal tDCS on the right IFG
sham tDCS
Arm Description
Outcomes
Primary Outcome Measures
Change in word total
total number of words in a language sample
Change in verb total
total number of verbs in a language sample
Change in utterance total
total number of utterances (complete sentences including a predicate and argument) in a language sample
Change in percent of Correct Information Units
The percent of accurately produced words that provide information relevant to the language task
Secondary Outcome Measures
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.
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'.
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).
Full Information
NCT ID
NCT04260815
First Posted
January 29, 2020
Last Updated
February 7, 2020
Sponsor
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT04260815
Brief Title
The Effect of Non-invasive Brian Stimulation on Language Production in Healthy Older Adults
Official Title
The Effect of Transcranial Direct-current Stimulation on Discourse Production in Healthy Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
August 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Disorders, Aphasia, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anodal tDCS on the left inferior frontal gyrus (IFG)
Arm Type
Experimental
Arm Title
anodal tDCS on the right IFG
Arm Type
Experimental
Arm Title
sham tDCS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial direct-current stimulation (tDCS)
Intervention Description
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 Outcome Measure Information:
Title
Change in word total
Description
total number of words in a language sample
Time Frame
pre-intervention and immediately after the intervention
Title
Change in verb total
Description
total number of verbs in a language sample
Time Frame
pre-intervention and immediately after the intervention
Title
Change in utterance total
Description
total number of utterances (complete sentences including a predicate and argument) in a language sample
Time Frame
pre-intervention and immediately after the intervention
Title
Change in percent of Correct Information Units
Description
The percent of accurately produced words that provide information relevant to the language task
Time Frame
pre-intervention and immediately after the intervention
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
7 days
Title
EPIC Physical Activity Questionnaire (EPAQ2)
Description
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'.
Time Frame
12 months
Title
The Keele Assessment of Participation (KAP)
Description
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).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 1UL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
10990547
Citation
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.
Results Reference
background
PubMed Identifier
29213226
Citation
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.
Results Reference
background
PubMed Identifier
21477637
Citation
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.
Results Reference
background
PubMed Identifier
2804622
Citation
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.
Results Reference
background
PubMed Identifier
23138766
Citation
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.
Results Reference
background
PubMed Identifier
8487525
Citation
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.
Results Reference
background
PubMed Identifier
16155776
Citation
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.
Results Reference
background
PubMed Identifier
6880820
Citation
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.
Results Reference
background
PubMed Identifier
11914316
Citation
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.
Results Reference
background
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The Effect of Non-invasive Brian Stimulation on Language Production in Healthy Older Adults
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