EpilepsyCADET PilotNCT05437393
Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
A study testing Deep brain stimulation in people with Epilepsy and Lennox-Gastaut Syndrome, Intractable, run by University College, London at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Epilepsy, Lennox-Gastaut Syndrome, Intractable
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 2 Jun 2023to 26 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
- -------------------------------
Who cannot join
- 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.
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- Have a nickel allergy
- Be pregnant
- Participate in contact sports
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Great Ormond Street Hospital NHS Foundation Trust
London
King's College Hospital NHS Foundation Trust
London
About this study
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).
Read the 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.
- Conditions
- Epilepsy, Lennox-Gastaut Syndrome, Intractable
- Being tested
- Deep brain stimulation
- Keywords
- Deep brain stimulation, Neurostimulation, Neuromodulation, Epilepsy, Lennox-Gastaut Syndrome
- Medical subject headings
- Epilepsy, Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
Deep brain stimulation of the centromedian nucleus (bilateral)
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation | Experimental | Deep Brain stimulation using a novel device: Bioinduction "Picostim" Deep Brain Stimulation system. Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse evens
Measured according to pre-determined device-related AEs and SAEs, as well as generic AEs and SAEs.
Measured: 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
Measured: Following 6-months of active stimulation
Participant completion of the study
Completion of all study activities at study exit
Measured: 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
Measured: Following 6-months of active stimulation
Secondary outcomes (5)
Relative change in parent-reported seizure frequency
Measured using parent-reported diaries
Measured: Following 6-months of active stimulation (compared to baseline)
Relative change in electrographic-recorded seizure frequency
Measured using serial electroencephalography (EEG)
Measured: 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.
Measured: Following 6-months of active stimulation (compared to baseline)
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.
Measured: 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.
Measured: Following 6-months of active stimulation (compared to baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start2 Jun 2023
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, King's College Hospital NHS Trust, University of Oxford, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437393
- Sponsor's protocol ID
- 141267
- Acronym
- CADET Pilot
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
- ClinicalTrials.gov ID
- NCT05437393
- Acronym / sponsor ID
- CADET Pilot / 141267
- Conditions
- Epilepsy, Lennox-Gastaut Syndrome, Intractable
- Keywords
- Deep brain stimulation, Neurostimulation, Neuromodulation, Epilepsy, Lennox-Gastaut Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, King's College Hospital NHS Trust, University of Oxford, King's College London
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulation | Experimental | Device: Deep brain stimulationDeep Brain stimulation using a novel device: Bioinduction "Picostim" Deep Brain Stimulation system. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Be 5-14 years of age at consent.
- Have a diagnosis of Lennox-Gastaut Syndrome, as determined by:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulationDeep brain stimulation of the centromedian nucleus (bilateral) | Device | Deep brain stimulation |
Primary outcome
Adverse evens
Time frame: 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
Time frame: Following 6-months of active stimulation
Consent at baseline
Participant completion of the study
Time frame: Following 6-months of active stimulation
Completion of all study activities at study exit
Ability of the participant/parent(s)/guardian(s) to re-charge and maintain the device
Time frame: Following 6-months of active stimulation
Device recharging is measured using the Picostim event logs
5 secondary outcomes
Relative change in parent-reported seizure frequency
Time frame: Following 6-months of active stimulation (compared to baseline)
Relative change in electrographic-recorded seizure frequency
Time frame: Following 6-months of active stimulation (compared to baseline)
Relative change in seizure severity
Time frame: Following 6-months of active stimulation (compared to baseline)
Relative change in quality of life
Time frame: Following 6-months of active stimulation (compared to baseline)
Relative change in quality of life
Time frame: Following 6-months of active stimulation (compared to baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Epilepsy and Lennox-Gastaut Syndrome, Intractable, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse evens (time frame: Following 6-months of active stimulation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.