NCT05437393Completed
Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
Source: ClinicalTrials.gov · Last updated 28 Aug 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 20 Jun 2022
- Start date
- 2 Jun 2023
- Primary completion date
- 26 Aug 2025
- Lead sponsor
- University College, London
- Diseases
- Epilepsy
- NCT number
- NCT05437393
What you commit to
- Study type: Interventional
- Participants enrolled: 4
- From 2 Jun 2023 to the primary completion date, 26 Aug 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Have a bleeding disorder.
- Have medical conditions/factors that would increase their anaesthetic risk to an unacceptable level.
- Have a nickel allergy
Other
- 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
Who the study is looking for
- 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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Age in the registry: 5 years to 14 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Great Ormond Street Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.