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 range5 Years – 14 Years
SexALL
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.
✓. 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.
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