The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial

A regiszterben nem jelölt feltételek

• Children enrolled in this study must:
• Be 5-14 years of age at consent.
• Have a diagnosis of LGS, as determined by:
  • Slow (<3.0Hz) spike-and-wave pattern and/or fast wave pattern (tonic seizures) detected on EEG at least six-months prior to the enrolment into the baseline period
  • History of drop seizures (tonic, atonic, or tonic-clonic) that precedes at least six-months prior to the enrolment into the baseline period
• Have experienced at least 10 seizures in the four weeks prior to enrolment.
• Have tried and not responded to two or more antiseizure medications prior to enrolment.
• Be taking one or more anti-seizure medication(s) at a stable dose for at least the four weeks prior to enrolment.
• Have a carer who is willing for their child's maintenance anti-seizure medications and ketogenic diet (if relevant) to be unaltered for the trial duration.
• Have a carer who is willing and able to comply with all the requirements of the study, including the completion of the seizure diary and periodic device charging.
  • Children enrolled in this study must not:
• Have received prior deep brain stimulation insertion.
• Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period).
• Have had a change in their anti-seizure medication prescription or stopped their ketogenic diet within the last 4 weeks
• Have started or made changes to the prescription of a ketogenic diet within the last 12-weeks
• Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.
• Have a bleeding disorder(s).
• Have a medical condition(s)/factor(s) that would increase their anaesthetic risk to an unacceptable level.
• Have a nickel allergy.
• Be pregnant.