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| Name | Class |
|---|---|
| Attune Neurosciences Inc | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target optimization using LIFU | Active Comparator | Participants in this single experimental group will undergo a series of LIFU sessions to determine optimal clinical response. Each participant will receive active LIFU stimulation of up to three personalized brain targets. The study utilizes a within-subject, sham-controlled design where participants receive both active LIFU and sham (placebo) stimulation across different sessions to compare physiological and clinical responses. |
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| Serial LIFU stimulation | Active Comparator | If an optimal target is identified, patients will undergo serial stimulation of the optimal target. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Frequency | Seizure counts will be obtained from a seizure diary kept by each participant. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| LIFU induced network change based on fMRI and/or electrophysiology | 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 4155087069 | lifu.research@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joline M Fan, MD, MS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39173737 | Background | Fan JM, Woodworth K, Murphy KR, Hinkley L, Cohen JL, Yoshimura J, Choi I, Tremblay-McGaw AG, Mergenthaler J, Good CH, Pellionisz PA, Lee AM, Di Ianni T, Sugrue LP, Krystal AD. Thalamic transcranial ultrasound stimulation in treatment resistant depression. Brain Stimul. 2024 Sep-Oct;17(5):1001-1004. doi: 10.1016/j.brs.2024.08.006. Epub 2024 Aug 22. No abstract available. |
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Individual participant data (IPD) will not be shared with outside researchers at this time to ensure the protection of participant privacy and to maintain strict compliance with the University of California San Francisco IRB approved protocol.
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Participants in this single experimental group will undergo a series of low-intensity focused ultrasound (LIFU) sessions to evaluate safety, tolerability, and preliminary efficacy. The study utilizes a within-subject, sham-controlled design where participants receive both active LIFU and sham (placebo) stimulation across different sessions to compare clinical response. Active LIFU stimulation sessions will assess up to three targets relevant to the epileptogenic network. If an optimal target is identified, patients will then undergo serial stimulation of the optimal target.
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| 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. |
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| Obtained at the baseline visit and the final day of serial stimulation, which averages around 4 months. |
| Cognitive battery | 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). | 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. |
| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D004827 | Epilepsy |
| D004829 | Epilepsy, Generalized |
| D004828 | Epilepsies, Partial |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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