Deep brain stimulation for children with Lennox-Gastaut syndrome
Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot
This study is testing whether deep brain stimulation can be safely used to help children with Lennox-Gastaut syndrome, a severe type of epilepsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 5 Years to 14 Years |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT05437393 on ClinicalTrials.gov |
What this trial studies
The CADET Pilot investigates the safety and feasibility of using deep brain stimulation (DBS) to treat children with Lennox-Gastaut syndrome, a severe form of epilepsy. In this single-arm, multi-site interventional trial, four children aged 5-14 will undergo a neurosurgical procedure to implant a novel DBS device. After a 30-day preoperative assessment and a month of inactive stimulation, the children will receive active stimulation for six months. This pilot aims to assess the safety and feasibility of the procedure rather than its efficacy.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-14 diagnosed with Lennox-Gastaut syndrome who have not responded to multiple antiseizure medications.
Not a fit: Patients who do not have Lennox-Gastaut syndrome or those who have not tried multiple antiseizure medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for children with drug-resistant epilepsy.
How similar studies have performed: While deep brain stimulation has been explored in adults with epilepsy, this specific application in children with Lennox-Gastaut syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
-------------------------------
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
Where this trial is running
London and 1 other locations
- Great Ormond Street Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Rory J Piper, MRCS
- Email: rory.piper.20@ucl.ac.uk
- Phone: 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.