Mapping LIFU Responses Using iEEG Recordings

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Low Intensity Focused Ultrasound
  The study visit consists of non-therapeutic transcranial low-intensity focused ultrasound pulses given while patient has intracranial electrodes implanted.

Первичные конечные точки

• Local spectral responses and temporally linked network activity, as measured by intracranial EEG [Срок оценки: 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 [Срок оценки: From enrollment to end of study is 2 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Pennsylvania — Philadelphia

Публикации

• 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. PMID 33781923
• Blackmore 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. PMID 31109842
• Kamimura 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. PMID 32509757
• Dallapiazza 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. PMID 28430035
• Verhagen 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. PMID 30747105
• Osada 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. PMID 38505983
• Dell'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. PMID 35547195
• Murphy 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. PMID 39933226

Идентификаторы

NCT: NCT07518927 · 860094

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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