Clinical trial NCT05437393: Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
Official title: Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Lennox-Gastaut Syndrome, Intractable
Keywords: Deep brain stimulation
Neurostimulation
Neuromodulation
Epilepsy
Lennox-Gastaut Syndrome
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: King's College Hospital NHS Trust
name: University of Oxford
name: King's College London
First posted: 2022-06-29
Enrollment: 4
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: INCLUSION CRITERIA:

Children enrolled in this study must:

1. Be 5-14 years of age at consent.
2. 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
3. Experience at least 10 seizures per month.
4. Have tried and not responded to two or more antiseizure medications prior to enrolment.
5. 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.
6. 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.
7. 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.

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EXCLUSION CRITERIA:

Children enrolled in this study must not:

1. Have had prior deep brain stimulation insertion.
2. Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period).
3. Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.
4. Have a bleeding disorder.
5. Have medical conditions/factors that would increase their anaesthetic risk to an unacceptable level.
6. Have a nickel allergy
7. Be pregnant
8. Participate in contact sports

Primary outcomes:
measure: Adverse evens
timeFrame: Following 6-months of active stimulation
measure: Willingness of the participants/parents/guardians for the participant to be recruited into the study and to undergo the intervention
timeFrame: Following 6-months of active stimulation
measure: Participant completion of the study
timeFrame: Following 6-months of active stimulation
measure: Ability of the participant/parent(s)/guardian(s) to re-charge and maintain the device
timeFrame: Following 6-months of active stimulation
Secondary outcomes:
measure: Relative change in parent-reported seizure frequency
timeFrame: Following 6-months of active stimulation (compared to baseline)
measure: Relative change in electrographic-recorded seizure frequency
timeFrame: Following 6-months of active stimulation (compared to baseline)
measure: Relative change in seizure severity
timeFrame: Following 6-months of active stimulation (compared to baseline)
measure: Relative change in quality of life
timeFrame: Following 6-months of active stimulation (compared to baseline)
measure: Relative change in quality of life
timeFrame: Following 6-months of active stimulation (compared to baseline)
Other outcomes:
measure: Radiological correlates of neurophysiological and clinical response to CMN DBS
timeFrame: Following 6-months of active stimulation
measure: Correlates of the scalp EEG with the intracranial recordings (local field potentials) from the DBS device.
timeFrame: Following 6-months of active stimulation
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References: