University of California, San Francisco
San Francisco, California, 94107, United States
Location status: Recruiting
Location contact
Joline M Fan, MD, MS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07680842
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.
Interested in participating?
Request Info21 year–65 year
All sexes
Interventional
Not applicable
San Francisco, California, 94107, United States
Location status: Recruiting
Joline M Fan, MD, MS
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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)
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.
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.
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).
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy
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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