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The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial

Sponsor: University College, London

NCT ID: NCT06924086

View on ClinicalTrials.gov ↗

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.

Lennox Gastaut Syndrome (LGS)

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What we know so far

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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
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.

Where Is This Study? (1 UK site)

Great Ormond Street Hospital NHS Foundation Trust

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

How to Get in Touch

Rory J Piper, MRCS, PhD

Sponsor contact

CONTACT

+44 20 7405 9200 Rory.Piper@ucl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-04