About this trial
The goal of this study is to investigate the effects of a non-invasive, low intensity focused ultrasound (LIFU) stimulation on seizure frequency and the epileptogenic network in drug-resistant epilepsy. LIFU uses focused sound waves to modulate deep brain regions and to enable changes in brain network activity. Encephalography (EEG) and behavioral tasks will also be used to study how LIFU affects brain activity.
Eligibility criteria
Qualifiers
Male or female between 21 and 65 years of age at screening
Clinical diagnosis of drug-resistant epilepsy with on average, 4 or more seizures per month.
Able to provide informed consent (or assent when applicable) by the subject or subject's legal representative.
Be willing to undergo a brain MRI.
Disqualifiers
Has a craniotomy or pathologic intracranial lesion (e.g. vascular malformations) in the trajectory of the focused ultrasound beam.
Pregnant, breastfeeding, is attempting pregnancy, or unwilling to practice birth control during participation in the study.
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Has any unstable medical or psychiatric disease.
Trial design
Treatments tested in this trial
- Target optimization using LIFU
- Serial LIFU stimulation
Treatment groups
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
Attune Neurosciences Inc
Collaborator