Adaptive deep brain stimulation for children with Lennox–Gastaut syndrome
The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): a Pivotal, Randomized, Controlled, Double-blinded Multi-site Clinical Trial of Deep Brain Stimulation to Treat Children With Lennox-Gastaut Syndrome
This trial will test adaptive deep brain stimulation using the Picostim device to try to reduce seizures in children aged 5–14 with Lennox–Gastaut syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 5 Years to 14 Years |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06924086 on ClinicalTrials.gov |
What this trial studies
The CADET program uses the non-CE/UKCA Picostim deep brain stimulation system to target seizure reductions in children with LGS; participants complete a 4-week baseline, undergo device implantation with a 4-week recovery, then enter a randomized, double-blind phase. Participants are assigned 1:1 to early stimulation (device on) or delayed stimulation (device off then turned on) with the primary analysis after 24 weeks of active stimulation. Secondary outcomes compare early versus delayed arms after the first 12 weeks of the controlled phase. The SMART-DBS sub-study specifically examines adaptive stimulation in children who already have an implanted Picostim device from the CADET pilot or main CADET enrollment.
Who should consider this trial
Good fit: Children aged 5–14 with a confirmed diagnosis of LGS who have had at least 10 seizures in the prior four weeks, have tried two or more antiseizure medications, are on stable medication regimens, and have caregivers willing to maintain treatments and attend visits; the SMART-DBS arm requires an existing implanted Picostim device from CADET studies.
Not a fit: Children outside the age range, with infrequent seizures, with medical contraindications to DBS, or whose caregivers cannot keep medications/diets stable or attend required follow-up visits are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this approach could lower seizure frequency and severity and improve daily functioning and quality of life for some children with LGS.
How similar studies have performed: Some adult DBS trials (for example anterior nucleus stimulation) have shown seizure reductions, but adaptive DBS in pediatric LGS is largely novel with very limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Children enrolled in this study must:
* 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.
Where this trial is running
London
- Great Ormond Street Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rory J Piper, MRCS, PhD
- Email: Rory.Piper@ucl.ac.uk
- Phone: +44 20 7405 9200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.