Status:
COMPLETED
Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
Lead Sponsor:
University College, London
Collaborating Sponsors:
Great Ormond Street Hospital for Children NHS Foundation Trust
King's College Hospital NHS Trust
Conditions:
Epilepsy
Lennox-Gastaut Syndrome, Intractable
Eligibility:
All Genders
5-14 years
Phase:
NA
Brief 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 3...
Detailed Description
The CADET pilot will be a single-arm, multi-site, interventional clinical trial. This design has been chosen since this is a feasibility and safety trial in a small number of patients and thus does no...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- \-------------------------------
- EXCLUSION CRITERIA:
- Children enrolled in this study must not:
- 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.
- Have a nickel allergy
- Be pregnant
- Participate in contact sports
Exclusion
Key Trial Info
Start Date :
June 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2025
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05437393
Start Date
June 2 2023
End Date
August 26 2025
Last Update
August 28 2025
Active Locations (2)
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1
Great Ormond Street Hospital NHS Foundation Trust
London, United Kingdom
2
King's College Hospital NHS Foundation Trust
London, United Kingdom