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New treatment option for Lennox Gastaut Syndrome (LGS)
Official title The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial
ClinicalTrials.gov ID: NCT06924086
What this study is testing
- What it's testing
- The CADET Trial will investigate the effectiveness of deep brain stimulation (DBS) to reduce the frequency of seizures in children with Lennox-Gastaut syndrome (LGS). The CADET Trial will use a non-CE/UKCA marked device - the Picostim DBS system.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 14
You may be able to join if
- 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...
- History of drop seizures (tonic, atonic, or tonic-clonic) that precedes at least six-months prior to the enrolment into the baseline period
See the full eligibility 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.