Adaptive deep brain stimulation for children with Lennox–Gastaut syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.