Phase 1 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 who have epilepsy that seriously affects their daily life and has not been controlled after trying at least 2 different anti-epileptic medications.
• People who have seizures that start in one area of the brain, which may or may not spread to the whole brain.
• People who have had a seizure assessment within the last 12 months, including brain wave monitoring (EEG), brain imaging (MRI or PET scan), and a cognitive/memory assessment using a specific test called the TOPF.
• People who have had an average of at least 3 seizures per month over the 3 months before joining the trial.
• People whose epilepsy and any psychiatric medications have been at a stable dose for at least 3 months before joining.
• People who score above 17 on a standard anxiety rating scale, indicating moderate to severe anxiety.
• People whose brain scan clearly shows a specific brain structure called the Anterior Nucleus.
• People who are willing to keep a daily seizure diary for 3 months before and 3 months after treatment.
• People who have a carer or support person involved in their care.
• People who are able and willing to give written consent to take part.
• People who are able to attend all required testing, appointments, and follow-up visits throughout the study.

Who may not be able to join:

• People who have fewer than 3 seizures per month on average.
• People with certain types of generalised epilepsy, including Lennox-Gastaut syndrome or seizures that cause sudden falls (drop attacks).
• People whose epilepsy was caused by a past infection (such as a herpes infection).
• People who are unwilling or unable to keep their anti-epilepsy medication at a stable dose for 3 months after treatment.
• People who have an active, uncontrolled psychiatric condition (diagnosed within the past 12 months) other than an anxiety disorder.
• People who have been diagnosed with a substance use disorder (drug or alcohol misuse) within the past 12 months.
• People who are currently experiencing, or have experienced in the past 30 days, thoughts of suicide.
• People who have a significant neurological condition other than epilepsy.
• People who show signs of a neurodegenerative disease — such as Parkinson's disease, Alzheimer's disease, or dementia with Lewy bodies — on neurological examination.
• People who have had multiple strokes, or a stroke within the past 6 months.
• People with significant structural abnormalities in the brain.
• People whose brain imaging shows a surgical lesion (an area that could be treated with surgery).
• People showing signs of increased pressure within the skull.
• People who have any type of brain tumour, including cancer that has spread to the brain.
• People who have previously had a vagal nerve stimulator implanted.
• People who have previously had a corpus callosotomy (a type of brain surgery for epilepsy).
• People who have previously had deep brain stimulation.
• People who have previously had a stereotactic ablation procedure (a targeted brain tissue treatment).
• People who test positive on a urine drug screen at the start of the study or at any follow-up visit (for cannabis, this applies if use was also reported within the past 48 hours).
• People with a known allergy or sensitivity to contrast dye used in medical imaging.
• People who cannot safely have an MRI scan — for example, due to a non-MRI-compatible metal implant such as a pacemaker, or due to body size limitations.
• People who have a history of claustrophobia (fear of enclosed spaces).
• People with certain unstable heart conditions, including unstable chest pain, a heart attack within the last 40 days, heart failure, or severe high blood pressure not controlled by medication.
• People who are currently receiving dialysis (kidney treatment).
• People with blood clotting or bleeding risk factors, including low platelet counts or abnormal clotting test results.
• People with a history of abnormal bleeding or a clotting disorder.
• People taking blood-thinning medications (such as warfarin or aspirin) within one week before the procedure, or certain other medications known to increase bleeding risk within one month before the procedure.
• People who have had a previous bleed inside the skull.
• People with an active, uncontrolled infection or a serious life-threatening illness.
• People with a weakened immune system, including those who are HIV positive.
• People with significant scalp thinning or poor skin healing ability.
• People whose CT scan shows calcium deposits that could interfere with the safety of the treatment.
• People whose skull density measurement (called Skull Density Ratio) is below 0.4, which may affect how well the treatment can work (confirm with trial site).
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period.
• People who have any other illness that the trial investigators believe would prevent safe participation.
• People who are unable or unwilling to lie still on their back for up to 4 hours during the treatment session.
• People who score below 70 on the TOPF cognitive assessment conducted during screening.
• People who score 24 or below on a standard cognitive test called the Mini Mental Status Examination (MMSE), indicating significant cognitive impairment.
• People who are unable to communicate with the trial team.
• People who do not have the legal capacity to consent to participation.

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