Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot (NCT05437393) | Clinical Trial Compass
CompletedNot Applicable
Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
United Kingdom4 participantsStarted 2023-06-02
Plain-language summary
The CADET Pilot will investigate the safety and feasibility of deep brain stimulation (DBS) to treat children with Lennox-Gastaut syndrome using a novel DBS device (Picostim DyNeuMo-1).
Following a 30-day preoperative/baseline assessment phase, all children will have a neurosurgical procedure to implant the device. Implantation will be followed by a 30-day phase of no stimulation (the device is off / inactive) and then a six-month phase of active stimulation (the device is on / active).
Who can participate
Age range
5 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be 5-14 years of age at consent.
. Have a diagnosis of Lennox-Gastaut Syndrome, as determined by:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse evens
Timeframe: Following 6-months of active stimulation
2
Willingness of the participants/parents/guardians for the participant to be recruited into the study and to undergo the intervention
Timeframe: Following 6-months of active stimulation
3
Participant completion of the study
Timeframe: Following 6-months of active stimulation
4
Ability of the participant/parent(s)/guardian(s) to re-charge and maintain the device
Timeframe: Following 6-months of active stimulation
. 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.
Exclusion criteria
. 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).
. Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.
. Have a bleeding disorder.
. Have medical conditions/factors that would increase their anaesthetic risk to an unacceptable level.