Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot

Epilepsy Clinical Trial

— CADET Pilot  

Official title:

Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437393
• Other study ID #: 141267
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2023
• Source: University College, London
• Contact: Rory J Piper, MRCS
• Phone: 20 7405 9200
• Email: rory.piper.20[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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. ------------------------------- 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

Related Conditions & MeSH terms

• Epilepsy
• Lennox Gastaut Syndrome

Intervention

Device:
• Deep brain stimulation
Deep brain stimulation of the centromedian nucleus (bilateral)

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital NHS Foundation Trust	London
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (5)

Lead Sponsor	Collaborator
University College, London	Great Ormond Street Hospital for Children NHS Foundation Trust, King's College Hospital NHS Trust, King's College London, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiological correlates of neurophysiological and clinical response to CMN DBS	Analysis of pre-trial MRI brain scan in conjunction with relative change in seizure counts measured using parent-reported diaries	Following 6-months of active stimulation
Other	Correlates of the scalp EEG with the intracranial recordings (local field potentials) from the DBS device.	Analysis of local-field potentials measured from the DBS device in conjunction with data from the encephalography (EEG) data	Following 6-months of active stimulation
Primary	Adverse evens	Measured according to pre-determined device-related AEs and SAEs, as well as generic AEs and SAEs.	Following 6-months of active stimulation
Primary	Willingness of the participants/parents/guardians for the participant to be recruited into the study and to undergo the intervention	Consent at baseline	Following 6-months of active stimulation
Primary	Participant completion of the study	Completion of all study activities at study exit	Following 6-months of active stimulation
Primary	Ability of the participant/parent(s)/guardian(s) to re-charge and maintain the device	Device recharging is measured using the Picostim event logs	Following 6-months of active stimulation
Secondary	Relative change in parent-reported seizure frequency	Measured using parent-reported diaries	Following 6-months of active stimulation (compared to baseline)
Secondary	Relative change in electrographic-recorded seizure frequency	Measured using serial electroencephalography (EEG)	Following 6-months of active stimulation (compared to baseline)
Secondary	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.	Following 6-months of active stimulation (compared to baseline)
Secondary	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.	Following 6-months of active stimulation (compared to baseline)
Secondary	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.	Following 6-months of active stimulation (compared to baseline)