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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
4
Deep brain stimulation of the centromedian nucleus (bilateral)
Great Ormond Street Hospital NHS Foundation Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Adverse evens
Measured according to pre-determined device-related AEs and SAEs, as well as generic AEs and SAEs.
Time frame: Following 6-months of active stimulation
Willingness of the participants/parents/guardians for the participant to be recruited into the study and to undergo the intervention
Consent at baseline
Time frame: Following 6-months of active stimulation
Participant completion of the study
Completion of all study activities at study exit
Time frame: Following 6-months of active stimulation
Ability of the participant/parent(s)/guardian(s) to re-charge and maintain the device
Device recharging is measured using the Picostim event logs
Time frame: Following 6-months of active stimulation
Relative change in parent-reported seizure frequency
Measured using parent-reported diaries
Time frame: Following 6-months of active stimulation (compared to baseline)
Relative change in electrographic-recorded seizure frequency
Measured using serial electroencephalography (EEG)
Time frame: Following 6-months of active stimulation (compared to baseline)
Relative change in seizure severity
Measured using the Hague Seizure Severity Scoring questionnaire. Minimum score = 13; maximum score = 52; with higher seizure severity with ascending values.
Time frame: Following 6-months of active stimulation (compared to baseline)
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Relative change in quality of life
Measured on the Pediatric Quality of Life Inventory (PedsQL) questionnaire. The minimum score is 0 and the maximum score is 100, with improving quality of life with ascending values.
Time frame: Following 6-months of active stimulation (compared to baseline)
Relative change in quality of life
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.
Time frame: Following 6-months of active stimulation (compared to baseline)