Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000633482
Ethics application status
Approved
Date submitted
10/01/2016
Date registered
17/05/2016
Date last updated
17/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brain excitability in children with benign focal epilepsies
Scientific title
Cortical excitability in children with benign focal epilepsies: Transcranial Magnetic Stimulation and EEG study
Secondary ID [1] 288266 0
None
Universal Trial Number (UTN)
U1111-1175-4189
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Focal Epilepsy of Childhood 297211 0
Condition category
Condition code
Neurological 297419 297419 0 0
Epilepsy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Children with Benign Focal Epilepsy of Childhood (BFEC), children with the BFEC trait (those with abnormal EEGs characteristic of BFEC but no history of seizures), unaffected siblings and parents of children with BFEC. Transcranial magnetic stimulation will be used to assess cortical excitability.
All participants will have TMS studies undertaken at enrolment. Children with BFEC or the EEG trait will have additional TMS studies undertaken at 6 months and 12 months after enrolment. Single or paired TMS pulses will be delivered to the right and left hemisphere and motor evoked potentials (MEPs) will be recorded in 2 of the following muscles of each hand: 1st dorsal interosseus, abductor pollicis brevis and abductor digiti minimi muscles. Surface emg electrodes (stick ons) will be used to record MEPs. The following measures of cortical excitation and inhibition will be recorded:
1. Resting motor threshold (RMT)
2. Stimulus amplitude to evoke an average MEP of 1mV
3. Recruitment curve (MEPs at varying stimulus intensity)
4. Intracortical excitation or facilitation (ICF) using paired pulse stimuli
5. Intracortical inhibition, short and long latency (SICI, LICI), using paired pulse stimulation
6. Late intracortical dysinhibition (LICD) using paired pulse stimulation
7. Ipsilateral silent period
The duration of the TMS study will be about 1 hour

All participants will have an Electro-encephalogram (EEG) recorded at enrolment as per standard PMH clinical protocol. Children with BFEC or EEG trait will have additional EEGs recorded at 6 months and 12 months after recruitment.
Intervention code [1] 293557 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296980 0
Cortical excitability will be compared between children with BFEC, their unaffected siblings and parents. Cortical excitability will be assessed using transcranial magnetic stimulation,
Timepoint [1] 296980 0
All participants will have TMS studies undertaken at enrolment. Children with BFEC or the EEG trait will have additional TMS studies undertaken at 6 months and 12 months after enrolment.
Secondary outcome [1] 319795 0
Cortical excitability (as assessed by the TMS study) will be correlated with EEG (background and epileptiform discharges).
Timepoint [1] 319795 0
All participants will have TMS and EEG studies undertaken at enrolment. Children with BFEC or the EEG trait will have additional TMS and EEG studies undertaken at 6 months and 12 months after enrolment.
Secondary outcome [2] 322234 0
In children with BFEC, cortical excitability (assessed by the TMS study) will be correlated with seizure burden for the previous 6 months (frequency, duration and severity). Seizure burden will be assessed from a seizure questionnaire (completed by the parent or carer) at enrolment. Further information regarding seizures will be obtained from a chart review. The seizure questionnaire was designed for this study for a condition where seizures are infrequent.
Timepoint [2] 322234 0
Children with BFEC will have TMS studies undertaken enrolment, and at 6 months and 12 months after enrolment.
Secondary outcome [3] 322235 0
In children with BFEC, cortical excitability (assessed by the TMS study) will be correlated seizure burden for the previous 6 months and with response to AEDs (if treated). Response to AED and seizure burden will be assessed from a seizure questionnaire (completed by the parent or carer) at enrolment, and at 6 months and 12 months after enrolment. Further information regarding seizures will be obtained from a chart review. Treatment with AEDs will be decided by their treating paediatrician or neurologist.
Timepoint [3] 322235 0
Children with BFEC will have TMS studies undertaken at enrolment, and 6 months and 12 months after enrolment. The seizure questionnaire was designed for this study for a condition where seizures are infrequent.

Eligibility
Key inclusion criteria
Children with BFEC diagnosed by their treating paediatrician or neurologist.
Children with BFEC trait diagnosed by their treating paediatrician or neurologist.
Siblings and parents of children with BFEC or BFEC trait.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with intellectual disability
Children unable to cooperate
Presence of magnetically or electrically sensitive implants such as cardiac pacemakers, stimulators, pumps, cochlear implants, etc.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Independent sample t tests, ANOVA and repeated measures ANOVA will be utilised to investigate the difference in the cortical excitability parameters (continuous variables) between groups. Chi-square tests will also be performed for categorical outcomes. We will further employ regression methods to investigate the associations of cortical excitability parameters with seizure frequency and treatment (On and Off AEDs).

Badawy et al. (2013a, Patterns of cortical hyperexcitability in adolescent/adult-onset generalized epilepsies. Epilepsia, 54(5):871–878) compared adult patients with different kinds of epilepsy; they were able to show significant differences between groups using a sample size of approx. 20 subjects in each group. We have a minimum sample size of 20 in each group. With the sample size we can detect an effect size (difference) of one standard deviation of a given continuous outcome variable between groups with a statistical power>80% and at the significance of 0.05. The one standard deviation is a large effect size that is commonly used for study design (Cohen J. A Power Primer. Physiol Bull 1992 112:155).

Sample size:
Children with BFEC, 20 participants
Children with EEG trait of BFEC, 20 participants
Asymptomatic siblings of children with BFEC or EEG trait, 20 participants
Parents of children with BFEC and EEG trait, 20 participants

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5004 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 12498 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 292646 0
Self funded/Unfunded
Name [1] 292646 0
None
Country [1] 292646 0
Primary sponsor type
Individual
Name
Clinical Professor Soumya Ghosh
Address
Dept. of Neurology, Princess Margaret Hospital for Children, Roberts Road,
Subiaco, W.A 6008
Country
Australia
Secondary sponsor category [1] 291363 0
None
Name [1] 291363 0
None
Address [1] 291363 0
Not applicable
Country [1] 291363 0
Other collaborator category [1] 278760 0
Individual
Name [1] 278760 0
Prof. Lakshmi Nagarajan
Address [1] 278760 0
Dept. of Neurology, Princess Margaret Hospital for Children, Roberts Road,
Subiaco, W.A 6008
Country [1] 278760 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294122 0
Child and Adolescent Health Ethics Committee
Ethics committee address [1] 294122 0
Ethics committee country [1] 294122 0
Australia
Date submitted for ethics approval [1] 294122 0
17/07/2014
Approval date [1] 294122 0
25/11/2014
Ethics approval number [1] 294122 0
2013107EP

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62570 0
Prof Soumya Ghosh
Address 62570 0
Dept. of Neurology, Princess Margaret Hospital for Children, Roberts Road,
Subiaco, W.A 6008
Country 62570 0
Australia
Phone 62570 0
+61 8 93408364
Fax 62570 0
+61 8 9340 7063
Email 62570 0
[email protected]
Contact person for public queries
Name 62571 0
Soumya Ghosh
Address 62571 0
Dept. of Neurology, Princess Margaret Hospital for Children, Roberts Road,
Subiaco, W.A 6008
Country 62571 0
Australia
Phone 62571 0
+61 8 93408364
Fax 62571 0
+61 8 9340 7063
Email 62571 0
[email protected]
Contact person for scientific queries
Name 62572 0
Soumya Ghosh
Address 62572 0
Dept. of Neurology, Princess Margaret Hospital for Children, Roberts Road,
Subiaco, W.A 6008
Country 62572 0
Australia
Phone 62572 0
+61 8 93408364
Fax 62572 0
+61 8 9340 7063
Email 62572 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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