TMS for iEEG Monitoring Recordings

Официальное название

Mapping Transcrnial Magnetic Stimulation (TMS) Responses Within the Brain Using Intracranial Electrophysiological Monitoring Recordings

Обзор

The current study presents a unique opportunity to measure the direct effects of transcranial magnetic stimulation (TMS) by using intracranial electrodes to record neural activity in deep brain regions when TMS single pulses are delivered. If TMS can evoke downstream responses in neural networks of the human brain, it can be a feasible way to study circuit engagement and connectivity.

Вмешательства

• Устройство Single Pulse TMS
  single pulse TMS will be administered when participants have intracranial electrodes implanted to measure neuronal activity.

Первичные конечные точки

• Primary Endpoint #1 Brain Activity and Connectivity [Срок оценки: From enrollment to the end of study participation at 5 weeks]
• Primary Endpoint #2: Safety Feasibility [Срок оценки: From enrollment to end of study participation at 5 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 neurological and/or psychiatric conditions at Pennsylvania Hospital
• 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 who are unable to have an MRI scan
• Patients who are unable to tolerate TMS
• Patients with additional implanted devices, such as an aneurysm clip or a cardiac pacemaker, that would increase the TMS risk profile
• 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

• Deng ZD, Lisanby SH, Peterchev AV. Electric field depth-focality tradeoff in transcranial magnetic stimulation: simulation comparison of 50 coil designs. Brain Stimul. 2013 Jan;6(1):1-13. doi: 10.1016/j.brs.2012.02.005. Epub 2012 Mar 21. PMID 22483681
• Trapp NT, Tsang EW, Bruss J, Russo S, Gander PE, Berger JI, Nourski KV, Rosanova M, Keller CJ, Oya H, Howard MA 3rd, Boes AD. TMS-associated auditory evoked potentials can be effectively masked: Evidence from intracranial EEG. Brain Stimul. 2024 May-Jun;17(3):616-618. doi: 10.1016/j.brs.2024.05.002. Epub 2024 May 8. No abstract available. PMID 38729299
• Solomon EA, Wang JB, Oya H, Howard MA, Trapp NT, Uitermarkt BD, Boes AD, Keller CJ. TMS provokes target-dependent intracranial rhythms across human cortical and subcortical sites. bioRxiv [Preprint]. 2023 Nov 19:2023.08.09.552524. doi: 10.1101/2023.08.09.552524. PMID 37645954
• Boes AD, Kelly MS, Trapp NT, Stern AP, Press DZ, Pascual-Leone A. Noninvasive Brain Stimulation: Challenges and Opportunities for a New Clinical Specialty. J Neuropsychiatry Clin Neurosci. 2018 Summer;30(3):173-179. doi: 10.1176/appi.neuropsych.17110262. Epub 2018 Apr 24. PMID 29685065
• Weiduschat N, Thiel A, Rubi-Fessen I, Hartmann A, Kessler J, Merl P, Kracht L, Rommel T, Heiss WD. Effects of repetitive transcranial magnetic stimulation in aphasic stroke: a randomized controlled pilot study. Stroke. 2011 Feb;42(2):409-15. doi: 10.1161/STROKEAHA.110.597864. Epub 2010 Dec 16. PMID 21164121
• Fitzgerald PB, Hoy K, McQueen S, Maller JJ, Herring S, Segrave R, Bailey M, Been G, Kulkarni J, Daskalakis ZJ. A randomized trial of rTMS targeted with MRI based neuro-navigation in treatment-resistant depression. Neuropsychopharmacology. 2009 Apr;34(5):1255-62. doi: 10.1038/npp.2008.233. Epub 2009 Jan 14. PMID 19145228
• Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on th PMID 31901449
• Zewdie E, Ciechanski P, Kuo HC, Giuffre A, Kahl C, King R, Cole L, Godfrey H, Seeger T, Swansburg R, Damji O, Rajapakse T, Hodge J, Nelson S, Selby B, Gan L, Jadavji Z, Larson JR, MacMaster F, Yang JF, Barlow K, Gorassini M, Brunton K, Kirton A. Safety and tolerability of transcranial magnetic and direct current stimulation in children: Prospective single center evidence from 3.5 million stimulati PMID 32289678

Идентификаторы

NCT: NCT07518745 · 857667

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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