Condition category
Mental and Behavioural Disorders
Date applied
25/07/2012
Date assigned
26/07/2012
Last edited
25/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Miss Elizabeth Shephard

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12083

Study information

Scientific title

Electrophysiology of LEarning and Cognitive control in children with Tourette syndrome with and without Attention-deficit/hyperactivity disorder

Acronym

ELECTA

Study hypothesis

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 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

Leicester NHS Research Ethics Committee - Nottinghamshire Healthcare NHS Trust, 13/03/2012, ref: 11/EM/0339

Study design

Non-randomised interventional single-centre trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Attention deficit hyperactivity conduct disorder

Intervention

Electrophysiological 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Performance variables and electrophysiological correlates of learning and cognitive control. Collected once from each participant in the next 12 months

Secondary outcome measures

No secondary outcome measures

Overall trial start date

14/03/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

UK Sample Size: 90

Participant exclusion criteria

1. 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

Recruitment start date

14/03/2012

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Industry

Funder name

Shire

Alternative name(s)

Shire plc

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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