Mapping LIFU Responses Using iEEG Recordings

April 1, 2026 updated by: Katherine Scangos, University of Pennsylvania

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. Adult patients, 21 to 75 years of age
  3. Patients considered to be in a stable medical condition, in the opinion of the PI
  4. Patients who are able to demonstrate comprehension of instructions in the English language, in the opinion of the PI
  5. Patients who are able to provide informed consent and fully comply with all study requirements, in the opinion of the PI

Exclusion Criteria:

  1. Patients with chronic alcohol abuse history
  2. Patients with additional implanted devices, such as an aneurysm clip, large cranial plates or mesh that may intersect with ultrasonic beam path
  3. Open scalp wounds, infection or dermatologic condition that preclude safe placement of ultrasound transducer
  4. Intracranial mass lesion with significant mass effect near intended beam path
  5. Patients who are pregnant at the time of screening or patients who get pregnant during the course of the study
  6. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFU Experiment
Device: Low Intensity Focused Ultrasound
The study visit consists of non-therapeutic transcranial low-intensity focused ultrasound pulses given while patient has intracranial electrodes implanted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local spectral responses and temporally linked network activity, as measured by intracranial EEG
Time Frame: From enrollment to end of study is two weeks
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
From enrollment to end of study is 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

March 4, 2031

Study Completion (Estimated)

March 4, 2031

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 860094

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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