CADET Pilot
Research type
Research Study
Full title
Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
IRAS ID
294472
Contact name
Martin Tisdall
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
The Children’s Adaptive Deep brain stimulation for Epilepsy Trial (CADET) Pilot will investigate the safety and feasibility of deep brain stimulation (DBS) for the treatment of children with Lennox-Gastaut syndrome (a rare yet severe form of childhood epilepsy). This will be a two-centre, single-arm, non-randomised clinical trial that will recruit four children (aged 5-15 years) with drug-resistant Lennox-Gastaut syndrome.
Following a 30-day baseline assessment phase, all children will have insertion of a DBS device that will deliver electrical stimulation to both the right and left the thalami of the brain. The device will be left inactive (switched off) for 30-days to allow the ‘lesioning effect’ of DBS insertion to dissipate. Following, all children will have their devices switched on and will receive a pre-defined regime of stimulation for 6-months. Following the end of the trial (6-months following device activation / 8-months following enrolment into the trial), children will have their devices maintained and managed by their clinical team as per their individual clinical requirements.
The primary objective is to determine the feasibility and safety of the intervention and device. The secondary objectives are to study the efficacy of DBS in reducing the number and severity of seizures, reducing the burden of epileptic activity on electroencephalography (EEG), and improving quality of life.
The trial will use a non-CE marked DBS device (Picostim (Bioinduction Ltd)). This DBS device has a battery that is non-invasively recharged by placing a charger over the skin (avoiding the need for frequent surgical replacements). The DBS device is mounted to the cranium (i.e. the battery/generator sits within a trough made in the skull), hopefully reducing device-associated pain, wire snapping with child growth, and reducing the risk of infection.
REC name
London - Queen Square Research Ethics Committee
REC reference
22/LO/0643
Date of REC Opinion
30 Nov 2022
REC opinion
Further Information Favourable Opinion