Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy
University of California, San Francisco
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.
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
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 ul…
Interventions
- DeviceTarget optimization using LIFU
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.
- DeviceSerial LIFU stimulation
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.
Location
- University of California, San FranciscoSan Francisco, California