Epilepsy Trial, Recruiting

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

Who might be able to join this trial:

• People aged 18 to 60 years old, of any gender
• People who have been diagnosed with epilepsy according to specific international diagnostic guidelines (ILAE 2014 criteria)
• People whose epilepsy has not been controlled by at least two different seizure medications (used alone or in combination) over at least six months, despite those medications being appropriate and tolerated
• People who have also been diagnosed with a heart condition called patent foramen ovale (PFO) — a small opening between the chambers of the heart — where blood is flowing in a particular direction (right-to-left) at a moderate or higher level, confirmed by a specialised ultrasound test
• People who have been on a stable seizure medication regimen for at least four weeks before screening, and who are willing to keep that regimen unchanged throughout the study
• People who have had at least one recorded seizure during a six-week screening period, and who report having had at least 12 seizures in the year before screening
• People who are able to fill in a seizure diary on their own or with help from a caregiver, and who are willing to attend required appointments and provide data
• People who are willing to undergo the study treatment and who are willing to provide written consent to participate

Who may not be able to join:

• People whose epilepsy has a known cause, such as an infection, a metabolic condition, an immune disorder, a genetic condition, or a structural brain abnormality
• People with a history of stroke or seizures that are not caused by epilepsy (known as psychogenic nonepileptic seizures)
• People who have previously had epilepsy surgery or an implanted brain stimulation device, or who are planning any such treatments — including a specialised diet for epilepsy — during the study
• People who have significant heart structural problems beyond PFO, such as moderate or severe leaking heart valves or high blood pressure in the lung's blood vessels
• People with serious brain or nervous system conditions, such as a recent stroke, a brain tumour, a brain infection, or a condition that is getting progressively worse
• People where imaging tests show signs of infection at the site where a needle would be inserted, or where the procedure would be technically difficult to perform (confirm with trial site)
• People who cannot take blood-thinning medications that work on platelets, due to a medical reason
• People with severe mental health conditions such as schizophrenia, bipolar disorder, or severe depression or anxiety
• People with a history of alcohol or other substance misuse
• People with serious problems affecting major organs — such as the heart, lungs, liver, or kidneys — that the trial doctor considers a risk to safety or to completing the study
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
• People who have taken part in another interventional clinical trial in the three months before signing consent, who are currently in another interventional trial, or who plan to join one during this study — or who are unable to attend follow-up appointments due to travel or relocation
• People with any other condition that the trial doctor considers makes participation unsuitable

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