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

Korábbi kezelés

• Have had prior deep brain stimulation insertion.
• Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period).

Más betegség

• Have a bleeding disorder.
• Have medical conditions/factors that would increase their anaesthetic risk to an unacceptable level.
• Have a nickel allergy

Egyéb

• Children enrolled in this study must not:
• Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.
• Be pregnant
• Participate in contact sports

• Children enrolled in this study must:
• Be 5-14 years of age at consent.
• 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 baseline period
  • History of drop seizures (tonic, atonic, or tonic-clonic) for at least six-months prior to the enrolment into the baseline period
• Experience at least 10 seizures per month.
• 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 and have a parent/guardian(s) who is willing for their child's maintenance anti-seizure drugs to be unaltered for the trial duration.
• If on a ketogenic diet, have been established on a stable ketogenic diet for at least 12 weeks prior to screening and the parent/guardian(s) to be willing for child to stay on a stable ketogenic for the duration of the trial.
• Have a parent/guardian(s) 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.
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