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 20 or older.
• People who have epilepsy that is limited to one area of the brain and has not responded to the maximum doses of at least two different seizure medications.
• People who have kept records of their seizure frequency for at least one month before the trial.
• People who have already completed a full pre-treatment assessment, including brainwave testing (EEG), brain scans (MRI), and a PET scan.
• People whose skull is suitable for the ultrasound treatment, based on a specific bone measurement called the Skull Density Ratio (SDR of 0.3 or above), confirmed by a CT scan.
• People whose body size allows them to fit inside an MRI machine and who are able to tolerate MRI scans.
• People who are able to stay awake and talk with the medical team during the procedure, as general anaesthesia is not used.
• People who are physically able to press a stop button during the procedure.
• People who are willing to have hair removed from the area being treated.

Who may not be able to join:

• People who cannot have an MRI scan for any reason, such as having certain metal implants in their body, having severe claustrophobia, or having had a bad reaction to contrast dyes used in scans.
• People who have implants in their brain or skull — such as drainage tubes (shunts), electrodes, skull patches, or electrode plates — that cannot be moved out of the path of the ultrasound treatment.
• People who have previous surgical sites, metal clips, or hard implants in their head that fall along the path of the ultrasound beam and cannot be avoided.
• People who have significant scarring on the scalp along the path of the intended ultrasound treatment.
• People who have received a contrast dye (used in MRI or ultrasound scans) within the 24 hours before the treatment.
• People who have other serious brain conditions, such as a brain aneurysm (a bulge in a blood vessel in the brain).
• People who have an increased risk of bleeding during or after the procedure, including those with a history of multiple strokes, a stroke in the past six months, a history of brain bleeding, or a bleeding or clotting disorder.
• People who are currently taking blood-thinning medications such as aspirin, warfarin (Coumadin), heparin, or newer anticoagulant tablets, unless these can be safely stopped for 3–7 days before treatment (confirm with trial site).
• People with severely uncontrolled high blood pressure that remains above certain levels even with medication (confirm with trial site for specific thresholds).
• People who are not able to communicate with the medical team during the procedure.
• People with an unstable heart condition, including a very fast or very slow heart rate, or very high or very low blood pressure at the time of treatment.
• People with a history of substance abuse (including misuse of medications or illegal drugs) or alcohol addiction.
• People who have taken medications that affect the brain or nervous system in the past six months (confirm with trial site for specific medication types).
• People who have been diagnosed with certain mental health conditions, such as schizophrenia, severe depression, or bipolar disorder.
• People who have serious injuries on the surface of their head, or who may be allergic to materials that come into contact with the head during treatment, such as conductive gels or silicone membranes.

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