NCT06924086

The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

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.

Conditions

• Lennox Gastaut Syndrome (LGS)

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	Picostim DBS Device

Timeline

• Start date: 2026-03-24
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2025-04-11
• Last updated: 2026-04-07

Locations

1 site across 1 country: United Kingdom