NCT05437393

Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

The CADET Pilot will investigate the safety and feasibility of deep brain stimulation (DBS) to treat children with Lennox-Gastaut syndrome using a novel DBS device (Picostim DyNeuMo-1). Following a 30-day preoperative/baseline assessment phase, all children will have a neurosurgical procedure to implant the device. Implantation will be followed by a 30-day phase of no stimulation (the device is off / inactive) and then a six-month phase of active stimulation (the device is on / active).

Detailed description

The CADET pilot will be a single-arm, multi-site, interventional clinical trial. This design has been chosen since this is a feasibility and safety trial in a small number of patients and thus does not primarily aim to determine efficacy. In this pilot clinical trial, four children with drug-resistant LGS will undergo bilateral CMN DBS. Following the DBS insertion, all children will undergo one month of inactive ('off') DBS in order to allow the lesioning effect of electrode implantation to dissipate. Thereafter, children will receive active ('on') DBS therapy with standard stimulation parameters for six-months. Following the 'on' phase of the trial, the child will then transition into continuing clinical care and will have their stimulation parameters altered according to clinical evaluation.

Conditions

• Epilepsy
• Lennox-Gastaut Syndrome, Intractable

Interventions

Type	Name	Description
DEVICE	Deep brain stimulation	Deep brain stimulation of the centromedian nucleus (bilateral)

Timeline

• Start date: 2023-06-02
• Primary completion: 2025-08-26
• Completion: 2025-08-26
• First posted: 2022-06-29
• Last updated: 2025-08-28

Locations

2 sites across 1 country: United Kingdom