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

Launched by UNIVERSITY COLLEGE, LONDON · Jun 24, 2022

Keywords

ClinConnect Summary

The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial, also known as the CADET Pilot, is studying a new treatment option for children with Lennox-Gastaut Syndrome, a severe form of epilepsy that often does not respond to standard medications. This trial will look at the safety and effectiveness of a special device called Picostim DyNeuMo-1, which delivers electrical stimulation to the brain to help reduce seizures. Children aged 5 to 14 who have been diagnosed with this syndrome and experience a significant number of seizures each month may be eligible to participate. To qualify, they must have tried at least two anti-seizure medications without success and must be stable on their current medication regimen for at least four weeks before joining the study.

If selected for the trial, children will first undergo a 30-day assessment period, followed by surgery to implant the device. After a month of not using the device, they will enter a six-month period where the device will be actively used to provide stimulation. Parents or guardians will play a key role in this study, as they will need to help keep track of their child's seizures and ensure they follow the study guidelines. This trial is important as it may offer a new way to help manage difficult-to-treat epilepsy in children.

Gender

ALL

Eligibility criteria

• 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 baseline period
• • History of drop seizures (tonic, atonic, or tonic-clonic) for at least six-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 to enrolment.
• • 5. 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.
• • 6. 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.
• • 7. 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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• 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 prior to the baseline period).
• • 3. Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.
• • 4. Have a bleeding disorder.
• • 5. Have medical conditions/factors that would increase their anaesthetic risk to an unacceptable level.
• • 6. Have a nickel allergy
• • 7. Be pregnant
• • 8. Participate in contact sports