Drug-Resistant EpilepsyNCT07680842
Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy
A study testing Target optimization using LIFU and Serial LIFU stimulation in people with Drug-Resistant Epilepsy and Epilepsy, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Drug-Resistant Epilepsy, Epilepsy, Epilepsy (Treatment Refractory)
- What is being tested?
- Target optimization using LIFU and Serial LIFU stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94107
Joline M Fan, MD, MS
About this study
Official title: Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment 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.
- Conditions
- Drug-Resistant Epilepsy, Epilepsy, Epilepsy (Treatment Refractory), Epilepsy Comorbidities, Epilepsy, Drug Resistant, Epilepsy, Generalized
- Being tested
- Target optimization using LIFU, Serial LIFU stimulation
- Keywords
- Seizures, Drug-Resistant Epilepsy, Epilepsy, Transcranial Ultrasound Stimulation, Focused ultrasound Stimulation, Electroencephalography (EEG), Low Intensity Focused ultrasound (LIFU)
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy, Epilepsy, Generalized, Epilepsies, Partial, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target optimization using LIFUDevice
Also called Low Intensity Focused Ultrasound (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.
Serial LIFU stimulationDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Target optimization using LIFU |
| Serial LIFU stimulation | Active comparator | If an optimal target is identified, patients will undergo serial stimulation of the optimal target. Receives: Device: Serial LIFU stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Frequency
Seizure counts will be obtained from a seizure diary kept by each participant.
Measured: 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.
Secondary outcomes (2)
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.
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start9 Jul 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug-Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Attune Neurosciences Inc
- Responsible party
- Sponsor
- Investigators
- Joline M Fan, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680842
- Sponsor's protocol ID
- 24-41317
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39173737
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT07680842
- Acronym / sponsor ID
- 24-41317
- Conditions
- Drug-Resistant Epilepsy, Epilepsy, Epilepsy (Treatment Refractory), Epilepsy Comorbidities, Epilepsy, Drug Resistant, Epilepsy, Generalized
- Keywords
- Seizures, Drug-Resistant Epilepsy, Epilepsy, Transcranial Ultrasound Stimulation, Focused ultrasound Stimulation, Electroencephalography (EEG), Low Intensity Focused ultrasound (LIFU)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Attune Neurosciences Inc
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Target optimization using LIFU | Active comparator | Device: Target optimization using LIFUParticipants 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. |
| Serial LIFU stimulation | Active comparator | Device: Serial LIFU stimulationIf an optimal target is identified, patients will undergo serial stimulation of the optimal target. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target optimization using LIFUAlso: Low Intensity Focused Ultrasound (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. | Device | Target optimization using LIFU |
| Serial LIFU stimulationAlso: 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. | Device | Serial LIFU stimulation |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 39173737Fan 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joline M Fan, MD, MS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target optimization using LIFU and Serial LIFU stimulation in people with Drug-Resistant Epilepsy and Epilepsy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (4155087069, lifu.research@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07680842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.