At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Deep Brain Stimulation (device)
- How long the study runs
- Study runs about 22 months (dates as stated)
- About the drug or intervention
- Deep Brain Stimulation — device: Picostim DBS Device
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 5 Years to 14 Years
- Who
- All
- Number of participants
- 22
- Started
- 2026-03-24
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for lennox gastaut syndrome (lgs)
- • NA - 22 participants
- • 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)
Who can take part?
- • Ages 5 Years to 14 Years
- • Diagnosed with lennox gastaut syndrome (lgs)
Where?
- • London - Great Ormond Street Hospital NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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 (1:1) and double-blinded to either an 'early stimulation' (DBS device switched on) or an 'delayed stimulation' (DBS device switched off) arm. Children allocated to receive early stimulation will complete 36 weeks of immediate active stimulation and children allocated to delayed stimulation will complete 12 weeks of inactive stimulation followed by 24 weeks of active stimulation. The primary endpoint for all participants in the trial will be following 24 weeks of active stimulation. Secondary outcomes will be compared between the early and delayed stimulation arms following the first 12 weeks of the controlled phase. The SMART-DBS study will recruit participants from the CADET Trial and the preceding CADET Pilot study. In both the CADET Trial and CADET Pilot studies, participants were fitted with the Picostim device and the device remains active. Participants who potentially meet the eligibility criteria will be provided with the PIS to consider participation in the adaptive DBS study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 5 Years - 14 Years
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓History of drop seizures (tonic, atonic, or tonic-clonic) that precedes at least six-months prior to the enrolment...
See the full criteria
Where Is This Study? (1 UK site)
Great Ormond Street Hospital NHS Foundation Trust
London, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700How to Get in Touch
Rory J Piper, MRCS, PhD
Sponsor contactCONTACT
