Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Ability of the participant/parent(s)/guardian(s) to re-charge and maintain the device
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children enrolled in this study must:
- •Be 5-14 years of age at consent.
- •Have a diagnosis of Lennox-Gastaut Syndrome, as determined by:
- •Slow (<3.0Hz) spike-and-wave pattern and/or fast wave pattern (tonic seizures) on EEG for at least six-months months prior to the enrolment into the baseline period
- •History of drop seizures (tonic, atonic, or tonic-clonic) for at least six-months prior to the enrolment into the baseline period
- •Experience at least 10 seizures per month.
- •Have tried and not responded to two or more antiseizure medications prior to enrolment.
- •Be taking one or more anti-seizure medication(s) at a stable dose for at least the four weeks prior and have a parent/guardian(s) who is willing for their child's maintenance anti-seizure drugs to be unaltered for the trial duration.
- •If on a ketogenic diet, have been established on a stable ketogenic diet for at least 12 weeks prior to screening and the parent/guardian(s) to be willing for child to stay on a stable ketogenic for the duration of the trial.
- •Have a parent/guardian(s) who is willing and able to comply with all the requirements of the study, including the completion of the seizure diary and periodic device charging.
- •-------------------------------
排除标准
- •Children enrolled in this study must not:
- •Have had prior deep brain stimulation insertion.
- •Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period).
- •Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.
- •Have a bleeding disorder.
- •Have medical conditions/factors that would increase their anaesthetic risk to an unacceptable level.
- •Have a nickel allergy
- •Be pregnant
- •Participate in contact sports
研究组 & 干预措施
Deep brain stimulation
Deep Brain stimulation using a novel device: Bioinduction "Picostim" Deep Brain Stimulation system.
干预措施: Deep brain stimulation (Device)
结局指标
主要结局
Ability of the participant/parent(s)/guardian(s) to re-charge and maintain the device
时间窗: Following 6-months of active stimulation
Device recharging is measured using the Picostim event logs
Adverse evens
时间窗: Following 6-months of active stimulation
Measured according to pre-determined device-related AEs and SAEs, as well as generic AEs and SAEs.
Participant completion of the study
时间窗: Following 6-months of active stimulation
Completion of all study activities at study exit
Willingness of the participants/parents/guardians for the participant to be recruited into the study and to undergo the intervention
时间窗: Following 6-months of active stimulation
Consent at baseline
次要结局
- Relative change in quality of life(Following 6-months of active stimulation (compared to baseline))
- Relative change in electrographic-recorded seizure frequency(Following 6-months of active stimulation (compared to baseline))
- Relative change in parent-reported seizure frequency(Following 6-months of active stimulation (compared to baseline))
- Relative change in seizure severity(Following 6-months of active stimulation (compared to baseline))