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:

• You must be at least 18 years old.
• You must be able to understand and sign a consent form agreeing to take part in the study.
• You have been diagnosed with epilepsy that has not responded well to medications, and you already have a vagus nerve stimulator (VNS) device implanted, OR you have been diagnosed with depression that has not responded well to treatments, and you already have a VNS device implanted.
• You have completed a related study called the REVEAL CSP and your care team has settled you on a stable VNS device setting.
• Other than epilepsy or depression, your general health and neurological health are stable.
• You are able and willing to attend regular in-person visits and phone appointments, including an imaging session, as required by the study.
• If you are able to become pregnant, you must be willing to use an acceptable form of birth control for the entire duration of the study (acceptable methods include abstinence, barrier methods, hormonal methods, sterilization, or fertility awareness).
• You must have active health insurance that covers standard healthcare costs and any study-related injuries.
• If joining as a depression participant: your depression symptoms must score at or above a certain level on a standard rating scale (MADRS score of 22 or higher) (confirm with trial site).
• If joining as an epilepsy participant: your VNS device must not have clearly helped control your seizures or related symptoms such as mood, thinking, or quality of life.

Who may not be able to join:

• You have any other implanted electrical stimulation device besides a VNS device placed for epilepsy or depression.
• You currently use or expect to use certain types of heat-based medical treatments, such as short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
• You have a substance use disorder (such as alcohol or drug dependency) that has not been in remission for at least 12 months.
• You have taken part in another drug or device study within the past 30 days (other than the REVEAL study).
• You have been hospitalised for a psychiatric condition in the past 6 months, or have had a history of psychosis (losing touch with reality) in the past 2 years (not counting episodes directly caused by a seizure).
• You have had a serious, prolonged seizure episode (status epilepticus) without a clear trigger in the past year (epilepsy applicants only).
• You are unwilling or unable to use your dominant arm during the study, or either of your upper arms measures more than 50 cm (about 20 inches) around.
• You have certain other health conditions that the study team considers would make participation unsafe, such as problems with blood circulation, severe blood pressure issues when standing, uncontrolled sleep apnea, chronic lung disease, or uncontrolled diabetes (confirm with trial site).
• You have paralysis of the vocal cords.
• You cannot speak and read English.
• You are currently pregnant.
• You are currently taking certain medications, including immunosuppressants, beta blockers, anticholinergics, or clonidine (in some cases, changing medications may be discussed with your doctor before joining).
• You weigh more than 350 pounds (159 kilograms), due to the limits of the equipment used in the study.
• You are unable or unwilling to eat eggs, due to allergy, intolerance, or strong dislike, as eggs are part of one of the study's required tests.
• If joining as a depression participant: you have been considered actively suicidal in the past 30 days, or have made a suicide attempt in the past 6 months.
• If joining as a depression participant: you have a history of certain serious mental health conditions such as schizophrenia, psychotic depression, severe personality disorder, or rapid cycling bipolar disorder.
• If joining as a depression participant: you have dementia or significant problems with memory or thinking.
• If joining as an epilepsy participant: your VNS device has clearly helped reduce your seizures or significantly improved your quality of life.
• Any other reason the study investigators believe would make participation unsafe or inappropriate for you.

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