Summary

Eligibility
for people ages 21-65 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Joline M Fan, MD, MS (ucsf)
Headshot of Joline M Fan
Joline M Fan

Description

Summary

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.

Official Title

Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy

Keywords

Drug-Resistant Epilepsy, Epilepsy, Epilepsy (Treatment Refractory), Epilepsy Comorbidities, Epilepsy, Drug Resistant, Epilepsy, Generalized, Epilepsy, Focal, Seizures, Transcranial Ultrasound Stimulation, Focused ultrasound Stimulation, Electroencephalography (EEG), Low Intensity Focused ultrasound (LIFU), Drug Resistant Epilepsy, Generalized Epilepsy, Partial Epilepsies, Target optimization using LIFU, Serial LIFU stimulation

Eligibility

You can join if…

Open to people ages 21-65

  • 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.
  • Be able and willing to wear a headband during the treatment duration.
  • Be able to complete scheduled visits and daily seizure logs.

You CAN'T join if...

  • 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.
  • Any contraindications for completing a brain MRI scan.
  • Has evidence of any other clinically relevant neurological disorder at the time of screening, including Alzheimer's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, and multiple sclerosis.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94107 United States

Lead Scientist at University of California Health

  • Joline M Fan, MD, MS (ucsf)
    Joline Fan, MD, MS, is an Assistant Professor at UCSF in the Departments of Neurology (Division of Epilepsy) and Psychiatry & Behavioral Sciences. Her research focuses on developing innovative neurostimulation technologies for neuropsychiatric disorders and exploring the complex relationship between sleep and epilepsy through multimodal neuroimaging.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07680842
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated