Sleep disturbance and learning in children with Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS)
| ISRCTN | ISRCTN66730162 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66730162 |
| EudraCT/CTIS number | 2011-001571-39 |
| Secondary identifying numbers | 1260 |
- Submission date
- 11/05/2011
- Registration date
- 13/07/2011
- Last edited
- 24/02/2020
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Benign epilepsy of childhood with centrotemporal spikes (BECCTS), also known as Benign Rolandic epilepsy, is one of the most common types of epilepsy in children. Unlike many other forms of epilepsy, BECCTS only affects children and the associated seizures usually disappear by the time the child is 16 years old. In most cases these seizures only happen when the child is asleep and do not last for very long. It has been found that sleep and drowsiness causes a surge of electrical activity in the centrotemporal region of the brain (centrotemporal spike). This form of epilepsy was previously considered to be harmless (benign) because it was thought to have no long-term ill-effects. However recent studies have shown that children who suffer from BECCTS may have mild learning difficulties. The exact cause of this is not known, as it could be due to the abnormal electrical activity in the brain or because of general interference with sleep. Sulthiame is an anticonvulsant drug which could be used to prevent these centrotemporal spikes, and helping to prevent sleep disturbances. The aim of this study is to find out if treatment with sulthiame could help to improve quality of sleep and help children to improve their learning skills.
Who can participate?
Children between the ages of 6 and 16 who have been diagnosed with BECCTS within the last 6 months.
What does the study involve?
Participants are randomly allocated into two groups, who each receive the treatments in a different order. Participants either take sulthiame for six weeks and then the placebo (dummy pill) for six weeks, or take the placebo for six weeks and then six weeks taking sulthiame. The correct dose of sulthiame is calculated for every child using their body weight. Between the sulthiame and placebo treatments, participants have a period of two weeks taking no medication (wash-out period). Before and after each of the treatments, children have their brain waves monitored during sleep and are given a number of tests to find out if their learning has improved.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Bristol Royal Hospital for Children (UK)
When is the study starting and how long is it expected to run for?
September 2011 to August 2013
Who is funding the study?
1. Epilepsy Research UK (UK)
2. Waterloo Foundation (UK)
Who is the main contact?
Dr Finbar O’Callaghan
finbar.ocallaghan@bristol.ac.uk
Contact information
Scientific
Level 6 Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
| Phone | +44 (0)117 342 0202 |
|---|---|
| finbar.ocallaghan@bristol.ac.uk |
Study information
| Study design | Randomised double blind placebo controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Investigating the relationship between sleep disturbance and learning in children with Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS): a randomised double blind placebo controlled crossover trial |
| Study acronym | BECCTS |
| Study objectives | 1. There will be an association between indices of sleep quality and strength of nocturnal versus daytime Consolidation of Learning in children with untreated BECCTS 2. Treatment of BECCTS will lead to the following changes relative to placebo: 2.1. Abolition of Interictal Epileptic Discharges (IEDs) during slow wave sleep (SWS) 2.2. Improved sleep quality [increased efficiency, reduced number of awakenings, density of sleep spindles and percentage rapid eye movement (REM) and percentage SWS] 2.3. Improved Consolidation of Learning (CoL) |
| Ethics approval(s) | South West Research Ethics Committee (Central Bristol), 31/10/21011, ref: 11/SW/0136 |
| Health condition(s) or problem(s) studied | Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS), also known as Benign Rolandic Epilepsy |
| Intervention | 1. Sulthiame versus placebo 2. Dose: 5 mg/kg/day 3. Administration: oral capsules, given at approximately 8 hour intervals 4. Duration: (Period A) 6 weeks of sulthiame or placebo, followed by a 2-week wash-out period, followed by (Period B) 6 weeks on the alternate treatment |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sulthiame |
| Primary outcome measure | 1. Frequency of Interictal Epileptic Discharges (IEDs) during slow wave sleep (SWS) on active treatment, relative to placebo, as measured by EEG at baseline, the end of treatment period A and the end of treatment period B 2. Sleep quality [efficiency, number of awakenings, density of sleep spindles and percentage rapid eye movement (REM) and percentage SWS on polysomnography] on active treatment relative to placebo, as measured at baseline, the end of treatment period A and the end of treatment period B 3. Performance on Consolidation of Learning (CoL) tasks on active treatment, relative to placebo, as measured (by validated CoL tools) at baseline, the end of treatment period A and at the end of treatment period B 4. Performance on cognitive assessments including IQ and event related potential (ERP) utilising the commonly employed auditory oddball paradigm as a measure of basic sensory processing and attention, as measured at baseline, the end of treatment period A and the end of treatment period B |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/09/2011 |
| Completion date | 31/08/2013 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 2 |
| Key inclusion criteria | 1. Male and female children 616 years of age 2. Within 6 months of diagnosis with BECCTS and the onset of symptoms 3. With clinical electroencephalography (EEG) characteristic consistent with typical BECCTS 4. With no current or prior treatment for BECCTS 5. Signed informed (parental) consent |
| Key exclusion criteria | 1. Inability to comply with assessments 2. Any serious intercurrent illness or uncontrolled disease which could compromise participation in the study 3. With contraindications for treatment with sulthiame: 3.1. History of hypersensitivity to sulphonamides 3.2. History of acute porphyria 3.3. History of hyperthyroidism 3.4. History of arterial hypertension 3.5. Impaired renal function 3.6. Psychiatric disorder 3.7. Hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption syndrome |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 31/08/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BS2 8AE
United Kingdom
Sponsor information
University/education
Research & Enterprise Development
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Website | http://www.bristol.ac.uk/red/ |
|---|---|
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- ERUK
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/02/2020: The following changes have been made:
1. The overall trial status and recruitment status have been changed to 'Stopped'.
2. The final enrolment number has been added.
19/01/2018: No publications found in PubMed, verifying study status with principal investigator.
