The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial
ConditionLennox Gastaut Syndrome (LGS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-14
SponsorUniversity College, London
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.
Eligibility criteria
Qualifiers
Be 5-14 years of age at consent.
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Deep Brain Stimulation
Treatment groups
22 Participants
are divided into 2 treatment groupsSponsors and collaborators
University College, London
Lead sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborator
King's College Hospital NHS Trust
Collaborator
University of Oxford
Collaborator
King's College London
Collaborator
Source ClinicalTrials.gov