Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

This study is investigating a new way to treat drug-resistant epilepsy using a non-invasive (no surgery) device called ATTN201. This device delivers low intensity focused ultrasound (LIFU) to specific areas of the brain to help reduce seizures. Researchers want to see if LIFU can change brain activity and lower the number of seizures you experience. You might be able to join if you are between 21 and 65 years old, have drug-resistant epilepsy with at least four seizures per month, and are willing to have a brain MRI and wear a headband during treatment. The main goal is to see how LIFU affects your seizure frequency. The current status of this study is unclear, and it plans to enroll 40 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants, but the phase of the study is not specified.
What's involved
You would undergo a brain MRI and wear a headband during treatment. Seizure counts will be recorded daily for about 4 months during the study, and for up to 2 months afterward.
Compensation
Not stated in the trial record.
Follow-up
Your seizure frequency will be monitored for up to 2 months after your final study visit.

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NCT07680842

Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

Recruiting
NAAges 21–65InterventionalTreatment
University of California, San Francisco
~40 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Target optimization using LIFUSerial LIFU stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Seizure Frequency
Measured over Seizure counts will be obtained daily for at least 1 month prior to the first study visit, throughout the study which averages around 4 months, and monitored for up to 2 months after the final visit.
Drug-Resistant Epilepsy
Epilepsy
Epilepsy (Treatment Refractory)
Epilepsy Comorbidities
Epilepsy, Drug Resistant
Epilepsy, Generalized
Epilepsy, Focal
1 sites across 1 states
California1
  • Joline M Fan, MD, MS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • Seizure FrequencySeizure counts will be obtained daily for at least 1 month prior to the first study visit, throughout the study which averages around 4 months, and monitored for up to 2 months after the final visit.

    Seizure counts will be obtained from a seizure diary kept by each participant.