CADET Trial
Research type
Research Study
Full title
The Children’s Adaptive Deep brain stimulation for Epilepsy Trial (CADET): a pivotal, randomized, controlled, double-blinded multi-site clinical trial of deep brain stimulation to treat children with Lennox-Gastaut syndrome
IRAS ID
354965
Contact name
Martin Tisdall
Contact email
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NIHR205474, Sub-study funder reference no. (NIHR)
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
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 DyNeuMo-2.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.
SMART-DBS will be a pilot trial of adaptive DBS for treating 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 receive therapy with an implanted Picostim DBS device. As part of this substudy, children will first complete 4-week baseline assessment period – including a seizure diary, questionnaires and EEG/LFP recording session. The child’s EEG collected in the baseline and prior trial period will be used to train a personalised seizure detector that can both count and enable an additional response to seizure onset (this is what makes the DBS ‘adaptive’).A personalised algorithm will be uploaded to the participant’s device. In the following 12-weeks the adaptive DBS will be activated on the device for 4-weeks, but no change in stimulation will be delivered to the child when it is activated. A repeat EEG will be performed to determine the effectiveness of the adaptive DBS in detecting seizures. The adaptive component of the DBS is activated/switched on and the child will complete a 24-week evaluation of this added therapy.
REC name
HSC REC A
REC reference
25/NI/0088
Date of REC Opinion
1 Jul 2025
REC opinion
Further Information Favourable Opinion