Status:
NOT_YET_RECRUITING
The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial
Lead Sponsor:
University College, London
Collaborating Sponsors:
Great Ormond Street Hospital for Children NHS Foundation Trust
King's College Hospital NHS Trust
Conditions:
Lennox Gastaut Syndrome (LGS)
Eligibility:
All Genders
5-14 years
Phase:
NA
Brief Summary
The CADET Trial will investigate the effectiveness of deep brain stimulation (DBS) to reduce the frequency of seizures in children with Lennox-Gastaut syndrome (LGS). The CADET Trial will use a non-CE...
Detailed Description
All participants will complete a 4 week baseline assessment phase, then surgical implantation of the Picostim device and then a 4 week recovery phase. The participants will thereafter be randomised (1...
Eligibility Criteria
Inclusion
- Children enrolled in this study must:
- Be 5-14 years of age at consent.
- Have a diagnosis of LGS, as determined by:
- Slow (\<3.0Hz) spike-and-wave pattern and/or fast wave pattern (tonic seizures) detected on EEG at least six-months prior to the enrolment into the baseline period
- History of drop seizures (tonic, atonic, or tonic-clonic) that precedes at least six-months prior to the enrolment into the baseline period
- Have experienced at least 10 seizures in the four weeks prior to enrolment.
- 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 to enrolment.
- Have a carer who is willing for their child's maintenance anti-seizure medications and ketogenic diet (if relevant) to be unaltered for the trial duration.
- Have a carer 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.
- Children enrolled in this study must not:
- Have received prior deep brain stimulation insertion.
- Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period).
- Have had a change in their anti-seizure medication prescription or stopped their ketogenic diet within the last 4 weeks
- Have started or made changes to the prescription of a ketogenic diet within the last 12-weeks
- Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.
- Have a bleeding disorder(s).
- Have a medical condition(s)/factor(s) that would increase their anaesthetic risk to an unacceptable level.
- Have a nickel allergy.
- Be pregnant.
Exclusion
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06924086
Start Date
January 1 2026
End Date
January 31 2028
Last Update
December 4 2025
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