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:

• Adults between 18 and 60 years of age.
• People who are able to give written consent to participate on their own behalf.
• People with epilepsy that has not responded to standard anti-seizure treatments for at least one year, with at least one seizure per month on average, and with seizure activity confirmed by brain wave (EEG) testing — as assessed through the NINDS Epilepsy Service under a separate screening protocol (18-N-0066), which prior or concurrent enrolment in is required.

Who may not be able to join:

• People with epilepsy who have been determined not to be candidates for surgery.
• People who have a significant brain abnormality shown on MRI, such as a brain tumour, stroke, brain damage from head trauma, or abnormal blood vessels in the brain.
• People who test positive for HIV.
• People who are pregnant or breastfeeding.
• People who experience severe claustrophobia that would make being inside an MRI machine uncomfortable.
• People who are unable to lie on their back for at least two hours.
• People who have a risk factor that makes MRI unsafe, such as a pacemaker, infusion pump, certain metal implants, body piercings that cannot be removed, or a history of working as a welder or metal worker (due to possible metal fragments in the eyes).
• People who are unwilling to allow their coded data from this study to be shared or used in future research.

For the MEMRI part of the study only (not applicable to all participants):

• People with a history of psychosis or aggression after seizures.
• People planning to become pregnant within the next two months.
• People with a significant history of liver or kidney disease that could increase the risk of harm from manganese exposure.
• People with a history of drug or alcohol misuse or dependence (as measured by a standard screening questionnaire).
• People whose blood test results show liver or kidney function values more than twice the upper limit of normal.
• People with a history of likely workplace exposure to manganese, such as working in a mine, foundry, smelter, battery manufacturing facility, or in agriculture involving manganese.
• People with a known allergy to manganese.
• People currently being treated with calcium-channel blocker medications.
• People with iron-deficiency anaemia.
• People with a personal history of Parkinson's disease or Parkinsonism, or who have a parent or sibling with this condition.

For the gadolinium-enhanced MRI part of the study only (not applicable to all participants):

• People whose kidney function (estimated GFR) is below 60, as tested within one week of the scan.
• People with a known allergy to gadolinium (a contrast dye used in some MRI scans).

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