Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
- Conditions
- EpilepsyLennox-Gastaut Syndrome, Intractable
- Interventions
- Device: Deep brain stimulation
- Registration Number
- NCT05437393
- Lead Sponsor
- University College, London
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Deep brain stimulation Deep brain stimulation Deep Brain stimulation using a novel device: Bioinduction "Picostim" Deep Brain Stimulation system.
- Primary Outcome Measures
Name Time Method Ability of the participant/parent(s)/guardian(s) to re-charge and maintain the device Following 6-months of active stimulation Device recharging is measured using the Picostim event logs
Adverse evens Following 6-months of active stimulation Measured according to pre-determined device-related AEs and SAEs, as well as generic AEs and SAEs.
Willingness of the participants/parents/guardians for the participant to be recruited into the study and to undergo the intervention Following 6-months of active stimulation Consent at baseline
Participant completion of the study Following 6-months of active stimulation Completion of all study activities at study exit
- Secondary Outcome Measures
Name Time Method Relative change in electrographic-recorded seizure frequency Following 6-months of active stimulation (compared to baseline) Measured using serial electroencephalography (EEG)
Relative change in quality of life Following 6-months of active stimulation (compared to baseline) Measured on the Impact of Pediatric Epilepsy Scale (IPES) questionnaires. The minimum score is 0 and the maximum score is 100, with improving quality of life with ascending values.
Relative change in parent-reported seizure frequency Following 6-months of active stimulation (compared to baseline) Measured using parent-reported diaries
Relative change in seizure severity Following 6-months of active stimulation (compared to baseline) Measured using the Hague Seizure Severity Scoring questionnaire. Minimum score = 13; maximum score = 52; with higher seizure severity with ascending values.
Trial Locations
- Locations (2)
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Great Ormond Street Hospital NHS Foundation Trust
🇬🇧London, United Kingdom