The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial
NCT ID: NCT06924086
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
22 participants
INTERVENTIONAL
2026-01-01
2028-01-31
Brief Summary
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The SMART-DBS study is a sub-study of the CADET Trial. SMART-DBS will investigate the application of adaptive DBS for the treatment of children with LGS. Children will be recruited after they exit from either the prior 'CADET Pilot Study' or 'CADET Trial' - meaning that these children will already be receiving therapy with an already implanted Picostim device.
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Detailed Description
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The primary endpoint for all participants in the trial will be following 24 weeks of active stimulation. Secondary outcomes will be compared between the early and delayed stimulation arms following the first 12 weeks of the controlled phase.
The SMART-DBS study will recruit participants from the CADET Trial and the preceding CADET Pilot study. In both the CADET Trial and CADET Pilot studies, participants were fitted with the Picostim device and the device remains active. Participants who potentially meet the eligibility criteria will be provided with the PIS to consider participation in the adaptive DBS study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Early stimulation
Active stimulation
Deep Brain Stimulation
Picostim DBS Device
Delayed stimulation
Inactive stimulation
Deep Brain Stimulation
Picostim DBS Device
Interventions
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Deep Brain Stimulation
Picostim DBS Device
Eligibility Criteria
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Inclusion Criteria
* Be 5-14 years of age at consent.
* Have a diagnosis of LGS, as determined by:
* Slow (\<3.0Hz) spike-and-wave pattern and/or fast wave pattern (tonic seizures) detected on EEG at least six-months prior to the enrolment into the baseline period
* History of drop seizures (tonic, atonic, or tonic-clonic) that precedes at least six-months prior to the enrolment into the baseline period
* Have experienced at least 10 seizures in the four weeks prior to enrolment.
* 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 to enrolment.
* Have a carer who is willing for their child's maintenance anti-seizure medications and ketogenic diet (if relevant) to be unaltered for the trial duration.
* Have a carer 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.
Children enrolled in this study must not:
* Have received prior deep brain stimulation insertion.
* Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period).
* Have had a change in their anti-seizure medication prescription or stopped their ketogenic diet within the last 4 weeks
* Have started or made changes to the prescription of a ketogenic diet within the last 12-weeks
* Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.
* Have a bleeding disorder(s).
* Have a medical condition(s)/factor(s) that would increase their anaesthetic risk to an unacceptable level.
* Have a nickel allergy.
* Be pregnant.
5 Years
14 Years
ALL
No
Sponsors
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Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
King's College Hospital NHS Trust
OTHER
University of Oxford
OTHER
King's College London
OTHER
University College, London
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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141268
Identifier Type: -
Identifier Source: org_study_id
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