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NCT Number: NCT07680842

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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94107, United States

Location status: Recruiting

Location contact

Joline M Fan, MD, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Target optimization using LIFU

Device

LIFU will be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Positioning is guided by an offline MRI scan, enabling non-invasive targeting of the LIFU beams directly to deep brain structures. Targeting will be determined based on the epileptogenic network.

Other names: Low Intensity Focused Ultrasound (LIFU)

Serial LIFU stimulation

Device

Serial LIFU will again be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Serial stimulation target selection will be based on the initial target optimization outcome, including the assessment of physiology and clinical treatment response.

Other names: Low Intensity Focused Ultrasound (LIFU)

Primary outcomes

  1. Seizure Frequency

    Time frame: 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.

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

Secondary outcomes

  1. LIFU induced network change based on fMRI and/or electrophysiology

    Time frame: Obtained at the baseline visit and the final day of serial stimulation, which averages around 4 months.

    Baseline and post-serial stimulation fMRI and scalp electroencephalogram (EEG) will be obtained and compared. To measure brain activity, individuals will undergo a 1-hour scalp EEG recording with sensors placed in a standard 10-20 montage array. Patients will be instructed to rest quietly and attempt sleep during this routine EEG. EEG outcome measures will include interictal epileptiform discharge frequency and spectral power changes in the delta to gamma frequency bands pre versus post stimulation.

  2. Cognitive battery

    Time frame: The cognitive battery will be performed at baseline visit, as well as at the beginning and end of routine study visits; the duration averages around a 4 month period.

    A cognitive battery will be performed before and following stimulation and will span elements of working memory, inhibition, and planning. The cognitive battery will constitute the N-back (working memory), flanker (inhibition), dimensional set-shifting (set-shifting), and visuospatial memory assessments (working spatial memory).

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

4155087069

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Attune Neurosciences Inc

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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