Low Intensity Focussed UltrasoundNCT07518927
Mapping LIFU Responses Using iEEG Recordings
A study testing Low Intensity Focused Ultrasound in people with Low Intensity Focussed Ultrasound and Electrodes, Implanted, run by University of Pennsylvania at 1 site in United States.
Trial summary
The current study presents a unique opportunity to measure the immediate neural responses to brief, non-therapeutic transcranial low-intensity focused ultrasound (LIFU) pulses using intracranial electrodes. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Low Intensity Focussed Ultrasound, Electrodes, Implanted
- What is being tested?
- Low Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2026to 4 Mar 2031
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who received (or are scheduled to receive) intracranial electrode implantation surgery as part of standard clinical care or as participation in an ongoing research study for the treatment of epilepsy and/or neuropsychiatric conditions at Pennsylvania Hospital (PAH) or Hospital of the University of Pennsylvania (HUP).
- Adult patients, 21 to 75 years of age
- Patients considered to be in a stable medical condition, in the opinion of the PI
- Patients who are able to demonstrate comprehension of instructions in the English language, in the opinion of the PI
- Patients who are able to provide informed consent and fully comply with all study requirements, in the opinion of the PI
Who cannot join
- Patients with chronic alcohol abuse history
- Patients with additional implanted devices, such as an aneurysm clip, large cranial plates or mesh that may intersect with ultrasonic beam path
- Open scalp wounds, infection or dermatologic condition that preclude safe placement of ultrasound transducer
- Intracranial mass lesion with significant mass effect near intended beam path
- Patients who are pregnant at the time of screening or patients who get pregnant during the course of the study
- Patients with any past or present medical condition, disease, disorder, or injury that, in the opinion of the PI, may reduce or hinder the participant's ability to fully comply with all study requirements or may impact, compromise, or affect the integrity of the data or the results of the study
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
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
About this study
Official title: Mapping Low-Intensity Focused Ultrasound (LIFU)-Evoked Brain Network Responses Using Intracranial Electrophysiological Recordings
The current study presents a unique opportunity to measure the immediate neural responses to brief, non-therapeutic transcranial low-intensity focused ultrasound (LIFU) pulses using intracranial electrodes. By recording time-locked signals in local and distant brain regions we can characterize circuit connectivity in real-time. We will use adult patients undergoing intracranial electrophysiological monitoring in an inpatient setting as our targeted population.
- Being tested
- Low Intensity Focused Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Focused UltrasoundDevice
The study visit consists of non-therapeutic transcranial low-intensity focused ultrasound pulses given while patient has intracranial electrodes implanted.
| Study group | Role | What they receive |
|---|---|---|
| LIFU Experiment | Experimental | Not described Receives: Device: Low Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local spectral responses and temporally linked network activity, as measured by intracranial EEG
Measured: From enrollment to end of study is two weeks
Safety, as defined by the number and type of adverse events (AE) and change in clinical VAS scales
Measured: From enrollment to end of study is 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start4 Mar 2026
- Primary completion4 Mar 2031 (estimated)
- Study completion4 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Low Intensity Focussed UltrasoundStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adult Patients undergoing intracranial electrophysiological monitoring in an inpatient setting are invited to participate in the one session of LIFU
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Scangos, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518927
- Sponsor's protocol ID
- 860094
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kakusa B, Huang Y, Barbosa DAN, Feng A, Gattas S, Shivacharan R, Lee EB, Kuijper FM, Saluja S, Parker JJ, Miller KJ, Keller C, Bohon C, Halpern CH. Anticipatory human subthalamic area beta-band power responses to dissociable tastes correlate with weight gain. Neurobiol Dis. 2021 Jul;154:105348. doi: 10.1016/j.nbd.2021.105348. Epub 2021 Mar 26.
PubMed 33781923Blackmore J, Shrivastava S, Sallet J, Butler CR, Cleveland RO. Ultrasound Neuromodulation: A Review of Results, Mechanisms and Safety. Ultrasound Med Biol. 2019 Jul;45(7):1509-1536. doi: 10.1016/j.ultrasmedbio.2018.12.015. Epub 2019 May 18.
PubMed 31109842Kamimura HAS, Conti A, Toschi N, Konofagou EE. Ultrasound neuromodulation: mechanisms and the potential of multimodal stimulation for neuronal function assessment. Front Phys. 2020 May;8:150. doi: 10.3389/fphy.2020.00150. Epub 2020 May 26.
PubMed 32509757Dallapiazza RF, Timbie KF, Holmberg S, Gatesman J, Lopes MB, Price RJ, Miller GW, Elias WJ. Noninvasive neuromodulation and thalamic mapping with low-intensity focused ultrasound. J Neurosurg. 2018 Mar;128(3):875-884. doi: 10.3171/2016.11.JNS16976. Epub 2017 Apr 21.
PubMed 28430035Verhagen L, Gallea C, Folloni D, Constans C, Jensen DE, Ahnine H, Roumazeilles L, Santin M, Ahmed B, Lehericy S, Klein-Flugge MC, Krug K, Mars RB, Rushworth MF, Pouget P, Aubry JF, Sallet J. Offline impact of transcranial focused ultrasound on cortical activation in primates. Elife. 2019 Feb 12;8:e40541. doi: 10.7554/eLife.40541.
PubMed 30747105Osada T, Konishi S. Noninvasive intervention by transcranial ultrasound stimulation: Modulation of neural circuits and its clinical perspectives. Psychiatry Clin Neurosci. 2024 May;78(5):273-281. doi: 10.1111/pcn.13663. Epub 2024 Mar 20.
PubMed 38505983Dell'Italia J, Sanguinetti JL, Monti MM, Bystritsky A, Reggente N. Current State of Potential Mechanisms Supporting Low Intensity Focused Ultrasound for Neuromodulation. Front Hum Neurosci. 2022 Apr 25;16:872639. doi: 10.3389/fnhum.2022.872639. eCollection 2022.
PubMed 35547195Murphy KR, Nandi T, Kop B, Osada T, Lueckel M, N'Djin WA, Caulfield KA, Fomenko A, Siebner HR, Ugawa Y, Verhagen L, Bestmann S, Martin E, Butts Pauly K, Fouragnan E, Bergmann TO. A practical guide to transcranial ultrasonic stimulation from the IFCN-endorsed ITRUSST consortium. Clin Neurophysiol. 2025 Mar;171:192-226. doi: 10.1016/j.clinph.2025.01.004. Epub 2025 Jan 28.
PubMed 39933226Darrow DP. Focused Ultrasound for Neuromodulation. Neurotherapeutics. 2019 Jan;16(1):88-99. doi: 10.1007/s13311-018-00691-3.
PubMed 30488340Kamimura HAS, Sokolov A. Transcranial magnetic resonance-guided focused ultrasound for neurological applications: industry challenges, innovations, and future directions. J Neural Eng. 2025 Apr 15;22(2). doi: 10.1088/1741-2552/adc8d2.
PubMed 40179892Darmani G, Ramezanpour H, Sarica C, Annirood R, Grippe T, Nankoo JF, Fomenko A, Santyr B, Zeng K, Vetkas A, Samuel N, Davidson B, Fasano A, Lankarany M, Kalia SK, Pichardo S, Lozano AM, Chen R. Individualized non-invasive deep brain stimulation of the basal ganglia using transcranial ultrasound stimulation. Nat Commun. 2025 Mar 19;16(1):2693. doi: 10.1038/s41467-025-57883-7.
PubMed 40108143Deveney CM, Surya JR, Haroon JM, Mahdavi KD, Hoffman KR, Enemuo KC, Jordan KG, Becerra SA, Kuhn T, Bystritsky A, Jordan SE. Transcranial focused ultrasound for the treatment of tremor: A preliminary case series. Brain Stimul. 2024 Jan-Feb;17(1):35-38. doi: 10.1016/j.brs.2023.12.007. Epub 2023 Dec 19.
PubMed 38128826Riis TS, Losser AJ, Kassavetis P, Moretti P, Kubanek J. Noninvasive modulation of essential tremor with focused ultrasonic waves. J Neural Eng. 2024 Feb 27;21(1). doi: 10.1088/1741-2552/ad27ef.
PubMed 38335553Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.
PubMed 34198105Lee CC, Chou CC, Hsiao FJ, Chen YH, Lin CF, Chen CJ, Peng SJ, Liu HL, Yu HY. Pilot study of focused ultrasound for drug-resistant epilepsy. Epilepsia. 2022 Jan;63(1):162-175. doi: 10.1111/epi.17105. Epub 2021 Nov 2.
PubMed 34729772
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Low-Intensity Focused Ultrasound (LIFU)-Evoked Brain Network Responses Using Intracranial Electrophysiological Recordings
- ClinicalTrials.gov ID
- NCT07518927
- Acronym / sponsor ID
- 860094
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 4 Mar 2031 (estimated)
- Study completion
- 4 Mar 2031 (estimated)
- First posted
- 9 Apr 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 current study presents a unique opportunity to measure the immediate neural responses to brief, non-therapeutic transcranial low-intensity focused ultrasound (LIFU) pulses using intracranial electrodes. By recording time-locked signals in local and distant brain regions we can characterize circuit connectivity in real-time. We will use adult patients undergoing intracranial electrophysiological monitoring in an inpatient setting as our targeted population.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adult Patients undergoing intracranial electrophysiological monitoring in an inpatient setting are invited to participate in the one session of LIFU
| Arm | Type | Receives |
|---|---|---|
| LIFU Experiment | Experimental | Device: Low Intensity Focused Ultrasound |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who received (or are scheduled to receive) intracranial electrode implantation surgery as part of standard clinical care or as participation in an ongoing research study for the treatment of epilepsy and/or neuropsychiatric conditions at Pennsylvania Hospital (PAH) or Hospital of the University of Pennsylvania (HUP).
- Adult patients, 21 to 75 years of age
- Patients considered to be in a stable medical condition, in the opinion of the PI
- Patients who are able to demonstrate comprehension of instructions in the English language, in the opinion of the PI
- Patients who are able to provide informed consent and fully comply with all study requirements, in the opinion of the PI
Key exclusion criteria (6 listed)
- Patients with chronic alcohol abuse history
- Patients with additional implanted devices, such as an aneurysm clip, large cranial plates or mesh that may intersect with ultrasonic beam path
- Open scalp wounds, infection or dermatologic condition that preclude safe placement of ultrasound transducer
- Intracranial mass lesion with significant mass effect near intended beam path
- Patients who are pregnant at the time of screening or patients who get pregnant during the course of the study
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 |
|---|---|---|
| Low Intensity Focused UltrasoundThe study visit consists of non-therapeutic transcranial low-intensity focused ultrasound pulses given while patient has intracranial electrodes implanted. | Device | LIFU Experiment |
Primary outcome
Local spectral responses and temporally linked network activity, as measured by intracranial EEG
Time frame: From enrollment to end of study is two weeks
Safety, as defined by the number and type of adverse events (AE) and change in clinical VAS scales
Time frame: From enrollment to end of study is 2 weeks
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 9 Apr 2026.
- Background: PubMed 33781923Kakusa B, Huang Y, Barbosa DAN, Feng A, Gattas S, Shivacharan R, Lee EB, Kuijper FM, Saluja S, Parker JJ, Miller KJ, Keller C, Bohon C, Halpern CH. Anticipatory human subthalamic area beta-band power responses to dissociable tastes correlate with weight gain. Neurobiol Dis. 2021 Jul;154:105348. doi: 10.1016/j.nbd.2021.105348. Epub 2021 Mar 26.
- Background: PubMed 31109842Blackmore J, Shrivastava S, Sallet J, Butler CR, Cleveland RO. Ultrasound Neuromodulation: A Review of Results, Mechanisms and Safety. Ultrasound Med Biol. 2019 Jul;45(7):1509-1536. doi: 10.1016/j.ultrasmedbio.2018.12.015. Epub 2019 May 18.
- Background: PubMed 32509757Kamimura HAS, Conti A, Toschi N, Konofagou EE. Ultrasound neuromodulation: mechanisms and the potential of multimodal stimulation for neuronal function assessment. Front Phys. 2020 May;8:150. doi: 10.3389/fphy.2020.00150. Epub 2020 May 26.
- Background: PubMed 28430035Dallapiazza RF, Timbie KF, Holmberg S, Gatesman J, Lopes MB, Price RJ, Miller GW, Elias WJ. Noninvasive neuromodulation and thalamic mapping with low-intensity focused ultrasound. J Neurosurg. 2018 Mar;128(3):875-884. doi: 10.3171/2016.11.JNS16976. Epub 2017 Apr 21.
- Background: PubMed 30747105Verhagen L, Gallea C, Folloni D, Constans C, Jensen DE, Ahnine H, Roumazeilles L, Santin M, Ahmed B, Lehericy S, Klein-Flugge MC, Krug K, Mars RB, Rushworth MF, Pouget P, Aubry JF, Sallet J. Offline impact of transcranial focused ultrasound on cortical activation in primates. Elife. 2019 Feb 12;8:e40541. doi: 10.7554/eLife.40541.
- Background: PubMed 38505983Osada T, Konishi S. Noninvasive intervention by transcranial ultrasound stimulation: Modulation of neural circuits and its clinical perspectives. Psychiatry Clin Neurosci. 2024 May;78(5):273-281. doi: 10.1111/pcn.13663. Epub 2024 Mar 20.
- Background: PubMed 35547195Dell'Italia J, Sanguinetti JL, Monti MM, Bystritsky A, Reggente N. Current State of Potential Mechanisms Supporting Low Intensity Focused Ultrasound for Neuromodulation. Front Hum Neurosci. 2022 Apr 25;16:872639. doi: 10.3389/fnhum.2022.872639. eCollection 2022.
- Background: PubMed 39933226Murphy KR, Nandi T, Kop B, Osada T, Lueckel M, N'Djin WA, Caulfield KA, Fomenko A, Siebner HR, Ugawa Y, Verhagen L, Bestmann S, Martin E, Butts Pauly K, Fouragnan E, Bergmann TO. A practical guide to transcranial ultrasonic stimulation from the IFCN-endorsed ITRUSST consortium. Clin Neurophysiol. 2025 Mar;171:192-226. doi: 10.1016/j.clinph.2025.01.004. Epub 2025 Jan 28.
- Background: PubMed 30488340Darrow DP. Focused Ultrasound for Neuromodulation. Neurotherapeutics. 2019 Jan;16(1):88-99. doi: 10.1007/s13311-018-00691-3.
- Background: PubMed 40179892Kamimura HAS, Sokolov A. Transcranial magnetic resonance-guided focused ultrasound for neurological applications: industry challenges, innovations, and future directions. J Neural Eng. 2025 Apr 15;22(2). doi: 10.1088/1741-2552/adc8d2.
- Background: PubMed 40108143Darmani G, Ramezanpour H, Sarica C, Annirood R, Grippe T, Nankoo JF, Fomenko A, Santyr B, Zeng K, Vetkas A, Samuel N, Davidson B, Fasano A, Lankarany M, Kalia SK, Pichardo S, Lozano AM, Chen R. Individualized non-invasive deep brain stimulation of the basal ganglia using transcranial ultrasound stimulation. Nat Commun. 2025 Mar 19;16(1):2693. doi: 10.1038/s41467-025-57883-7.
- Background: PubMed 38128826Deveney CM, Surya JR, Haroon JM, Mahdavi KD, Hoffman KR, Enemuo KC, Jordan KG, Becerra SA, Kuhn T, Bystritsky A, Jordan SE. Transcranial focused ultrasound for the treatment of tremor: A preliminary case series. Brain Stimul. 2024 Jan-Feb;17(1):35-38. doi: 10.1016/j.brs.2023.12.007. Epub 2023 Dec 19.
Related trials for Low Intensity Focussed Ultrasound
Active, not recruitingEarly Phase 1
Pharmacological Mechanisms of Low-intensity Focused Ultrasound for Motor Cortex Neuroplasticity
Low Intensity Focussed Ultrasound
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Focused Ultrasound in people with Low Intensity Focussed Ultrasound and Electrodes, Implanted, run by University of Pennsylvania 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 5 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: enrolling by invitation, as of the sponsor's last update on 9 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local spectral responses and temporally linked network activity, as measured by intracranial EEG (time frame: From enrollment to end of study is two weeks). The study lists 2 primary outcomes in all. 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 NCT07518927, which also lists 27 linked publications.
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 9 Apr 2026.