TMS for iEEG Monitoring Recordings

NCT07518745 | Enrolling By Invitation FDA Device

• 1 other identifier: 857667
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

EEG; TMS

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint #1 Brain Activity and Connectivity

  Observation of effects in brain activity and connectivity within and across regions of interest before and after TMS, as measured by intracranial EEG. The evoked response magnitude from the EEG at all features of the time-frequency analysis are used.

  From enrollment to the end of study participation at 5 weeks

• Primary Endpoint #2: Safety Feasibility

  Safety, as defined by the number of adverse events (AE)

  From enrollment to end of study participation at 5 weeks.

Study Arms (1)

TMS

EXPERIMENTAL

The study visit consists of a TMS single-pulse session when intracranial electrodes are implanted to record neural activity during the TMS session.

Device: Single Pulse TMS

Interventions

Single Pulse TMS DEVICE

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

TMS

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (15)

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• 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.

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• 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.

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• 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 stimulations. Brain Stimul. 2020 May-Jun;13(3):565-575. doi: 10.1016/j.brs.2019.12.025. Epub 2019 Dec 30.

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• Chervyakov AV, Chernyavsky AY, Sinitsyn DO, Piradov MA. Possible Mechanisms Underlying the Therapeutic Effects of Transcranial Magnetic Stimulation. Front Hum Neurosci. 2015 Jun 16;9:303. doi: 10.3389/fnhum.2015.00303. eCollection 2015.

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• Varnerin N, Mirando D, Potter-Baker KA, Cardenas J, Cunningham DA, Sankarasubramanian V, Beall E, Plow EB. Assessment of Vascular Stent Heating with Repetitive Transcranial Magnetic Stimulation. J Stroke Cerebrovasc Dis. 2017 May;26(5):1121-1127. doi: 10.1016/j.jstrokecerebrovasdis.2016.12.030. Epub 2017 Jan 20.

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• Shimojima Y, Morita H, Nishikawa N, Kodaira M, Hashimoto T, Ikeda S. The safety of transcranial magnetic stimulation with deep brain stimulation instruments. Parkinsonism Relat Disord. 2010 Feb;16(2):127-31. doi: 10.1016/j.parkreldis.2009.09.006. Epub 2009 Oct 6.

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• Wang JB, Hassan U, Bruss JE, Oya H, Uitermarkt BD, Trapp NT, Gander PE, Howard MA 3rd, Keller CJ, Boes AD. Effects of transcranial magnetic stimulation on the human brain recorded with intracranial electrocorticography. Mol Psychiatry. 2024 May;29(5):1228-1240. doi: 10.1038/s41380-024-02405-y. Epub 2024 Feb 5.

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• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

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• Phielipp NM, Saha U, Sankar T, Yugeta A, Chen R. Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. Clin Neurophysiol. 2017 Jun;128(6):1109-1115. doi: 10.1016/j.clinph.2017.01.021. Epub 2017 Feb 13.

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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 a TMS session while implanted with electrodes.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: November 11, 2025
• Primary Completion (Estimated): October 11, 2029
• Study Completion (Estimated): November 11, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)