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Trial registered on ANZCTR

Registration number

ACTRN12618001821280

Ethics application status

Approved

Date submitted

21/10/2018

Date registered

9/11/2018

Date last updated

23/04/2021

Date data sharing statement initially provided

9/11/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Brain Stimulation in Childhood Refractory Epilepsy

Scientific title

Transcranial Direct Current Stimulation for treatment of Children and
Adolescents with Refractory Epilepsy

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1186-0038

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Epilepsy

Condition category

Condition code

Neurological

Epilepsy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Transcranial Direct Current Stimulation (tDCS)
tDCS will be applied using the NeuroConn DC stimulator. Surface stimulation will be applied using established protocols for cortical inhibition (usually 1-2mA for 15-60 minutes, 1-5 days per week for 1-2 weeks) at the discretion of neurologist.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Changes in the type, frequency and duration of seizures for 2 weeks before and after tDCS will be compared based on seizure diary (maintained for 2 weeks prior to tDCS, during tDCS and 2 weeks after tDCS).

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Comparison of seizure frequency (based on patient diary) for 2 weeks prior and 2 weeks after treatment.

Timepoint [1]

For 2 weeks before and after completion of treatment, then 3 and 6 months after treatment.

Secondary outcome [1]

Comparison of seizure duration and severity (composite measure based on patient diary) for 2 weeks prior and 2 weeks after treatment.

Timepoint [1]

For 2 weeks before and after completion of treatment, then 3 and 6 months after treatment..

Secondary outcome [2]

Comparison of epileptiform activity (spike counts) on EEG 1 week before and after treatment.

Timepoint [2]

1 week after treatment, then 3 and 6 months after treatment.

Secondary outcome [3]

Quality of Life Questionnaire (QOLCE, Sabaz et al. 2000)

Timepoint [3]

single time points 1-2 weeks before treatment, 1-2 weeks, 3 months and 6 months after treatment.

Secondary outcome [4]

Changes in cortical excitability assessed with TMS (Resting or active motor threshold) 1-2 weeks before and after treatment.

Timepoint [4]

single time point 1-2 weeks before and 1-2 weeks after treatment.

Secondary outcome [5]

Changes in cortical excitability assessed with TMS (intra-cortical facilitation) 1-2 weeks before and after treatment.

Timepoint [5]

single time point 1-2 weeks before and 1-2 weeks after treatment

Secondary outcome [6]

Changes in cortical excitability assessed with TMS (intra-cortical inhibition) 1-2 weeks before and after treatment.

Timepoint [6]

single time point 1-2 weeks before and 1-2 weeks after treatment

Eligibility

Key inclusion criteria

1) Children with refractory epilepsy (CRE), age 2 years or above
2) CRE who have trialled at least 4 AEDs (or 3 AEDs and a ketogenic diet)
3) CRE in whom epilepsy surgery is not a suitable option or where parents refuse surgery

Minimum age

2 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) Children less than 2 years
2) Children in whom EEG cannot be undertaken
3) Children with significant psychiatric disorders
4) Children with implants not compatible with tDCS or TMS (e.g. cardiac pacemekers)

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

None

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Before and after treatment comparison. Open label trial.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

We plan to recruit 10 children with focal epilepsy and 10 with generalized epilepsy to investigate consistent effects of tDCS in children with refractory epilepsy. The patient acts as his/her own control.
Appropriate statistical analyses (t-test, ANOVA) will be used to compare:
Seizure frequency and duration before and after tDCS (as calculated from seizure diaries kept for 2 weeks before tDCS, 2 weeks immediately after tDCS and at 3 months and 6 months after tDCS)
Epileptic burden on EEG will be assessed by doing spike counts (interictal epileptiform activity) before and after tDCS
QOLCE scores before and after tDCS
Cortical excitability parameters assessed by TMS before and after tDCS.
Subgroup analysis will be performed to evaluate if beneficial effects of tDCS are related to type of epilepsy or other patient chanracteristics.
Corrections will be made for multiple comparisons.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

14/04/2015

Date of last participant enrolment

Anticipated

14/04/2022

Actual

Date of last data collection

Anticipated

14/10/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Recruitment hospital [2]

Perth Children's Hospital - Nedlands

Recruitment postcode(s) [1]

6008 - Subiaco

Recruitment postcode(s) [2]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Perth Children's Hospital

Address [1]

Hospital Avenue Nedlands WA 6009 Australia

Country [1]

Australia

Primary sponsor type

Individual

Name

Clinical Professor Lakshmi Nagarajan

Address

Perth Children’s Hospital
15 Hospital Avenue, Nedlands | Locked Bag 2010,
Nedlands WA 6909

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Perth Children's Hospital Human Research Ethics Committee

Ethics committee address [1]

Perth Children’s Hospital, 15 Hospital Avenue, Nedlands, Nedlands WA 6909

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/11/2013

Approval date [1]

20/03/2014

Ethics approval number [1]

HREC REF 2013114

Summary

Brief summary

Non-invasive brain stimulation with transcranial Direct Current Stimulation (tDCS) is being increasingly trialled for the treatment of neurological disorders such as stroke and epilepsy. Epilepsy is known to be associated with alteration in brain excitability. tDCS is a safe and painless neurophysiological method used to alter the excitability of the brain. Childhood epilepsy is refractory to medical management in 30% of children, and other options (e.g. surgery) are not appropriate in many. Newer techniques such as tDCS are being trialled and show promise as treatment options. There are, however, only a few studies involving small numbers that have been reported so far, and more trials with tDCS in epilepsy are needed. Our study plans to evaluate the use of tDCS in children with refractory epilepsy, to assess the types of seizures that will respond to tDCS, the stimulation protocols that produce optimal benefit, and to evaluate any other beneficial and adverse effects.

This study uses clinical assessments, EEG and transcranial magnetic stimulation (TMS) to monitor the effects of tDCS. Parents will be required to maintain a seizure diary to help evaluate the effects of tDCS.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Lakshmi Nagarajan

Address

Perth Children’s Hospital, 15 Hospital Avenue,
Nedlands WA 6909

Country

Australia

Phone

+61 8 64564333

Fax

+61 8 64562325

[email protected]

Contact person for public queries

Name

Linda Palumbo

Address

Perth Children’s Hospital, 15 Hospital Avenue,
Nedlands WA 6909

Country

Australia

Phone

+61 8 64564333

Fax

+61 8 64562325

[email protected]

Contact person for scientific queries

Name

Soumya Ghosh

Address

Perth Children’s Hospital, 15 Hospital Avenue,
Nedlands WA 6909

Country

Australia

Phone

+61 8 64564333

Fax

+61 8 64562325

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Funding not avaialable.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Tolerability and Effectiveness of Cathodal Transcranial Direct Current Stimulation in Children with Refractory Epilepsy: A Case Series.	2023	https://dx.doi.org/10.3390/brainsci13050760

N.B. These documents automatically identified may not have been verified by the study sponsor.

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