Brain Stimulation in Childhood Refractory Epilepsy

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001821280

Enrollment

Registered

2018-11-09

Start date

2015-04-14

Completion date

2022-04-14

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

2 Years to 18 Years

Healthy volunteers

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

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)

Outcome results