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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Deep Brain Stimulation
DevicePicostim DBS Device
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Early stimulationActive comparator 1 intervention
Group B: Delayed stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Seizure frequency reduction
Seizure frequency reduction measured on carer-recorded seizure diaries
Time frame
24 weeks of active stimulation compared to baselineSecondary outcomes
1
Seizure frequency
Seizure frequency reduction measured on carer-recorded seizure diaries
Time frame
8-12 weeks following randomisation between the active and inactive stimulation arms2
Seizure frequency
Seizure frequency reduction measured on scalp EEG
Time frame
24 weeks of active stimulation compared to baseline3
Seizure frequency
Seizure frequency reduction measured on scalp EEG
Time frame
8-12 weeks following randomisation between the active and inactive stimulation arms4
Seizure severity
Seizure severity (according to the Hague Seizure Severity Scale). The HSSS scores range from 13 (least severe) and to 53 (most severe).
Time frame
24 weeks of active stimulation relative to baseline and comparison 12 weeks following randomisation between the active and inactive armsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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