Epilepsy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children who are between 5 and 14 years old at the time of consent
• Children who have been diagnosed with Lennox-Gastaut Syndrome (LGS), confirmed by a specific abnormal brain wave pattern seen on a brainwave test (EEG) at least six months before the study starts
• Children who have a history of drop seizures (where the body suddenly stiffens, goes limp, or convulses) that began at least six months before the study starts
• Children who have had at least 10 seizures in the four weeks before joining the study
• Children who have already tried two or more seizure medications without those medications working well enough
• Children who are currently taking one or more seizure medications at a consistent, unchanged dose for at least the four weeks before joining
• Children whose carer is willing to keep the child's seizure medications and ketogenic diet (if the child follows one) unchanged for the entire duration of the trial
• Children whose carer is willing and able to follow all study requirements, including filling in a seizure diary and regularly charging a medical device

Who may not be able to join:

• Children who have previously had a deep brain stimulation (DBS) device surgically inserted
• Children who have an active vagus nerve stimulator (a device that sends signals to the brain via a nerve in the neck), or who had one switched on within the six months before the study baseline period
• Children whose seizure medication has been changed or stopped within the last four weeks
• Children whose ketogenic diet was started or changed within the last 12 weeks
• Children whose brain scans show an abnormality in a specific part of the brain (the thalamus) that would make deep brain stimulation unsafe or not possible
• Children who have a bleeding disorder
• Children who have a medical condition that would make the risks of general anaesthesia too high (confirm with trial site)
• Children who have a nickel allergy
• Children who are pregnant

Important: Always verify eligibility with the trial site directly before applying.