Actively Recruiting
The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial
Led by University College, London · Updated on 2026-04-07
22
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
G
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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/UKCA marked device - the Picostim DBS system. The SMART-DBS study is a sub-study of the CADET Trial. SMART-DBS will investigate the application of adaptive DBS for the treatment of children with LGS. Children will be recruited after they exit from either the prior 'CADET Pilot Study' or 'CADET Trial' - meaning that these children will already be receiving therapy with an already implanted Picostim device.
CONDITIONS
Official Title
The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 5-14 years of age at consent
- Have a diagnosis of Lennox-Gastaut syndrome (LGS) confirmed by EEG patterns and history of drop seizures for at least six months
- Have experienced at least 10 seizures in the four weeks prior to enrolment
- Have tried and not responded to two or more anti-seizure medications prior to enrolment
- Be taking one or more anti-seizure medications at a stable dose for at least four weeks before enrolment
- Have a carer willing to keep anti-seizure medications and ketogenic diet unchanged during the trial
- Have a carer able to comply with study requirements including seizure diary completion and device charging
You will not qualify if you...
- Prior deep brain stimulation insertion
- Active vagus nerve stimulator use or use within six months before baseline
- Changes to anti-seizure medication or ketogenic diet within the last 4 weeks
- Started or changed ketogenic diet within the last 12 weeks
- Abnormal thalamic anatomy making DBS unsafe or unfeasible
- Bleeding disorders
- Medical conditions increasing anaesthetic risk
- Nickel allergy
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Great Ormond Street Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
Research Team
R
Rory J Piper, MRCS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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