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OpenTrials
Enrolling by Invitation

NCT Number: NCT07518927

Mapping LIFU Responses Using iEEG 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.

Enrolling by Invitation

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Key information

Conditions

Low Intensity Focussed Ultrasound Electrodes, Implanted

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From enrollment to end of study is two weeks

  2. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Mapping Low-Intensity Focused Ultrasound (LIFU)-Evoked Brain Network Responses Using Intracranial Electrophysiological Recordings

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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