Electrical brain activity patterns in children with Tourette syndrome and ADHD

ISRCTN ISRCTN19093443
DOI https://doi.org/10.1186/ISRCTN19093443
Secondary identifying numbers 12083
Submission date
25/07/2012
Registration date
26/07/2012
Last edited
25/08/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Tourette syndrome (TS) is a disorder that begins in childhood. Children with TS have difficulty controlling involuntary movements and sounds (tics). The cause of TS is unknown and treatments used to control tics are often not effective. Frequently, children with TS also have symptoms of attention-deficit/hyperactivity disorder (ADHD). These symptoms include poor attention, hyperactivity (being unable to keep still for long) and impulsivity (being unable to wait). Children with symptoms of TS and ADHD are referred to as having ‘comorbid’ TS+ADHD. These children have more serious problems at school and home and are more difficult to treat successfully than children without comorbid ADHD. This study aims to improve understanding of the causes of these conditions, particularly the reasons for and impact of having ADHD in addition to TS.
We will examine the patterns of brain activity associated with ‘learning’ (the process of acquiring new behaviours) and ‘cognitive control’ (the ability to voluntarily control behaviour) in children with TS, ADHD and TS+ADHD and unaffected children. Learning and cognitive control are controlled by the same brain networks that are thought to be different in children with TS and ADHD. Studying the basis of these cognitive functions in TS and TS+ADHD should therefore reveal important insights into the causes of these conditions. Participants will perform a computerised task designed to tap learning and cognitive control while their brain activity is recorded with a technique called ‘electroencephalography’ (EEG). We will compare differences in brain activity patterns across participant groups to establish differences between TS, ADHD and unaffected children in these cognitive functions, and to examine how such differences interact in TS+ADHD.

Who can participate?
Young people with a diagnosis of TS, ADHD or TS+ADHD can take part if they are aged between 9-17 years and do not have an autistic spectrum disorder (ASD) or severe learning difficulty. Young people aged 9-17 years can take part in the typically developing control group if they do not have a diagnosis of any developmental condition.

What does the study involve?
The study consists of two parts. Part 1 consists of an interview session with each participant’s parent/carer to assess the presence or absence of developmental problems. Part 2 of the study is an EEG recording session in which the participant has their brain activity measured using EEG while they perform two computer tasks. EEG is a non-invasive and painless technique in which a cap is placed on the participant’s head and electrodes are placed in holes on the cap to record the brain activity at the scalp.

What are the possible risks and benefits of participating?
The possible benefits of participating are to gain first-hand experience of taking part in a research study, and to contribute to research which we hope will help improve understanding of the causes of two developmental disorders. We anticipate no risks resulting from taking part.

Where is the study run from?
University of Nottingham (UK)

When is the study starting and ending?
The study began in March 2012 and we hope to finish testing participants by February 2013. Analysis should be complete by September 2013.

Who is funding the study?
University of Nottingham and Shire Pharmaceuticals plc.

Who is the main contact?
Miss Elizabeth Shephard
mcxes@nottingham.ac.uk

Contact information

Miss Elizabeth Shephard
Scientific

Division of Psychiatry
School of Community Health
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Study information

Study designNon-randomised interventional single-centre trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleElectrophysiology of LEarning and Cognitive control in children with Tourette syndrome with and without Attention-deficit/hyperactivity disorder
Study acronymELECTA
Study objectivesTourette syndrome (TS) is a disorder that begins in childhood. Children with TS have difficulty controlling involuntary movements and sounds (tics). The cause of TS is unknown and treatments used to control tics are often ineffective. Frequently, children with TS also have symptoms of attention-deficit/hyperactivity disorder (ADHD). These symptoms include poor attention, hyperactivity (being unable to keep still for long) and impulsivity (being unable to wait). Children with symptoms of TS and ADHD are referred to as having ‘comorbid’ TS+ADHD. These children have more serious problems at school and home and are more difficult to treat successfully than children without comorbid ADHD. This study aims to improve understanding of the causes of these conditions, particularly the reasons for and impact of having ADHD in addition to TS. We will examine patterns of electrophysiological brain activity associated with ‘associative learning’ (learning behaviours by strengthening associations between behaviours and responses) and ‘cognitive control’ (voluntary control of behaviour) in children with TS, ADHD, TS+ADHD, and unaffected controls. Associative learning and cognitive control are controlled by the same brain networks that are thought to be atypical in TS and ADHD. Studying the neural basis of these cognitive functions in TS and TS+ADHD should therefore reveal important insights into the causes of these conditions. Participants will perform a computerised task designed to tap associative learning and cognitive control while their electrophysiological brain activity is recorded with electroencephalography (EEG). Behavioural and electrophysiological measures of associative learning and cognitive control will be compared across participant groups to establish differences between TS, ADHD and controls in these cognitive functions, and to examine how such differences interact in TS+ADHD.
Ethics approval(s)Leicester NHS Research Ethics Committee - Nottinghamshire Healthcare NHS Trust, 13/03/2012, ref: 11/EM/0339
Health condition(s) or problem(s) studiedAttention deficit hyperactivity conduct disorder
InterventionElectrophysiological testing, Each participant will complete an electrophysiological testing session in which they will perform a computerised learning and cognitive control task while their electrophysiological brain activity is recorded by electrodes placed on the scalp (technique known as electroencephalography or EEG)
Follow Up Length: 12 month(s)
Intervention typeOther
Primary outcome measurePerformance variables and electrophysiological correlates of learning and cognitive control. Collected once from each participant in the next 12 months
Secondary outcome measuresNo secondary outcome measures
Overall study start date14/03/2012
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participantsUK Sample Size: 90
Key inclusion criteria1. Diagnosis of TS without diagnosis of ADHD (children and adolescents with TS without ADHD)
2. Diagnosis of ADHD without diagnosis of TS (children and adolescents with ADHD without TS)
3. Diagnosis of TS with ADHD symptoms (children adolescents with TS with ADHD)
4. Male & Female
Key exclusion criteria1. Known neurological problem that would likely influence brain function e.g. epilepsy
2. Diagnosed learning difficulties or IQ score less than 70 points as this may prevent participants being able to perform the task
3. Diagnosis of any psychiatric condit
Date of first enrolment14/03/2012
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Division of Epidemiology and Public Health
Nottingham
NG7 2RD
England
United Kingdom

Website http://www.nottingham.ac.uk/
ROR logo "ROR" https://ror.org/01ee9ar58

Funders

Funder type

Industry

Shire
Private sector organisation / For-profit companies (industry)
Alternative name(s)
Shire plc
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

25/08/2016: No publications found, verifying study status with principal investigator.