Mapping LIFU Responses Using iEEG Recordings

NCT07518927 | Enrolling By Invitation FDA Device

• 1 other identifier: 860094
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Low Intensity Focussed Ultrasound; Electrodes, Implanted

Outcome Measures

Primary Outcomes (2)

• Local spectral responses and temporally linked network activity, as measured by intracranial EEG

  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

  From enrollment to end of study is 2 weeks

Study Arms (1)

LIFU Experiment

EXPERIMENTAL

Device: Low Intensity Focused Ultrasound

Interventions

Low Intensity Focused Ultrasound DEVICE

The study visit consists of non-therapeutic transcranial low-intensity focused ultrasound pulses given while patient has intracranial electrodes implanted.

LIFU Experiment

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (27)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: Adult Patients undergoing intracranial electrophysiological monitoring in an inpatient setting are invited to participate in the one session of LIFU

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): March 4, 2031
• Study Completion (Estimated): March 4, 2031
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)