Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot

INCLUSION CRITERIA:

Children enrolled in this study must:

1. Be 5-14 years of age at consent.

2. Have a diagnosis of Lennox-Gastaut Syndrome, as determined by:

• Slow (<3.0Hz) spike-and-wave pattern and/or fast wave pattern (tonic seizures)on EEG for at least six-months months prior to the enrolment into the baselineperiod

• History of drop seizures (tonic, atonic, or tonic-clonic) for at leastsix-months prior to the enrolment into the baseline period

3. Experience at least 10 seizures per month.

4. Have tried and not responded to two or more antiseizure medications prior toenrolment.

5. Be taking one or more anti-seizure medication(s) at a stable dose for at least thefour weeks prior and have a parent/guardian(s) who is willing for their child'smaintenance anti-seizure drugs to be unaltered for the trial duration.

6. If on a ketogenic diet, have been established on a stable ketogenic diet for atleast 12 weeks prior to screening and the parent/guardian(s) to be willing for childto stay on a stable ketogenic for the duration of the trial.

7. Have a parent/guardian(s) who is willing and able to comply with all therequirements of the study, including the completion of the seizure diary andperiodic device charging.

EXCLUSION CRITERIA:

Children enrolled in this study must not:

1. Have had prior deep brain stimulation insertion.

2. Have an active ('on') vagus nerve stimulator (or active within the six months priorto the baseline period).

3. Have abnormal thalamic anatomy detected on imaging that would render DBS eitherunsafe or unfeasible.

4. Have a bleeding disorder.

5. Have medical conditions/factors that would increase their anaesthetic risk to anunacceptable level.

6. Have a nickel allergy

7. Be pregnant

8. Participate in contact sports