Ensayos clínicos

Inclusion Criteria:

• Subject must be at least 18 years old.
• Participant must have the capacity to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
• Participant is diagnosed with drug Resistant Epilepsy, with continuing seizures despite adequate trials of at least 2 appropriate anti-seizure drugs (ASDS) with therapeutic serum concentrations (as per the International League Against Epilepsy (ILAE) Commission on Therapeutic Strategies) (44).
• Apart from epilepsy, subject should be medically and neurologically stable.
• Subject is able to complete regular office visits and telephone appointments including the 2 imaging sessions in accordance with the study protocol requirements.
• Subject is adequately protected from conception, or willing to use an acceptable method of birth control over the entire study duration if of childbearing potential.
• Subject has been informed of his or her eligibility for resective surgery as a potential alternative to the study if such surgery is a reasonable option.

Exclusion Criteria:

• Subject has a prior implantable stimulation device, other than a VAS device for the clinical indication of refractory focal Epilepsy.
• Subject currently uses or during the study is expected to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.       
• Subject has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer.
• Subject participated in another drug or device trial within the preceding 30 days (other than REVEAL studies).
• Subject has been hospitalized for a psychiatric condition within the preceding 6 months or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis).
• Subject has experienced unprovoked status epilepticus in the preceding year.
• Subject with vocal cord paralysis
• Any other factor that may impact participant safety or compliance as per PI.
• Subject cannot speak and read English.
• Prohibited Therapy During Study Period: We will exclude patients on immunosuppressants, beta blockers, anticholinergics, and clonidine. Consultation with primary providers and amending some of these therapies may be allowed only if clinically indicated. In that case, participants will have to be stable on their new medication for at least one month prior to implant.
• A body weight of over 350 pounds or 159 kilograms due to equipment limitations used in the measurements of gastric accommodation and emptying.
• An inability to eat eggs whether due to an allergy, intolerance, or strong dislike. The gastric emptying test meal contains eggs that are labeled with radioisotope. Other food substitutions for the toast, butter and milk may be made only if prior approval is given by Dr. Camilleri.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/2/24.  Questions regarding updates should be directed to the study team contact.