Brain excitability in children with benign focal epilepsies

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000633482
• Date of registration: 17/05/2016
• Prospective Registration: No
• Primary sponsor: Clinical Professor Soumya Ghosh
• 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
• Date of first enrolment: 01/01/2016
• Target sample size: 80
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616000633482.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Soumya Ghosh

• Name: Prof Soumya Ghosh

Key inclusion & exclusion criteria

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.
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.


Age minimum: 5 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Epilepsy

Benign Focal Epilepsy of Childhood;
Benign Focal Epilepsy of Childhood

Intervention(s)

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.

Primary Outcome(s)

Cortical excitability will be compared between children with BFEC, their unaffected siblings and parents. Cortical excitability will be assessed using transcranial magnetic stimulation, [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(s)

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.
[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.
]

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.
[Children with BFEC will have TMS studies undertaken enrolment, and at 6 months and 12 months after enrolment.]

Cortical excitability (as assessed by the TMS study) will be correlated with EEG (background and epileptiform discharges).
[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 ID(s)

None

Source(s) of Monetary Support

None

Ethics review

Status: Approved
Approval date:
Contact:

Child and Adolescent Health Ethics Committee