- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07518745
TMS for iEEG Monitoring Recordings
April 27, 2026 updated by: Katherine Scangos, University of Pennsylvania
Mapping Transcrnial Magnetic Stimulation (TMS) Responses Within the Brain Using Intracranial Electrophysiological Monitoring Recordings
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
10
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
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- University of Pennsylvania
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-
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:
- 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
Exclusion Criteria:
- 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
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: TMS
The study visit consists of a TMS single-pulse session when intracranial electrodes are implanted to record neural activity during the TMS session.
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single pulse TMS will be administered when participants have intracranial electrodes implanted to measure neuronal activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Endpoint #2: Safety Feasibility
Time Frame: From enrollment to end of study participation at 5 weeks.
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Safety, as defined by the number of adverse events (AE)
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From enrollment to end of study participation at 5 weeks.
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Primary Endpoint #1 Brain Activity and Connectivity
Time Frame: From enrollment to the end of study participation at 5 weeks
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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.
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From enrollment to the end of study participation at 5 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Kuncel AM, Grill WM. Selection of stimulus parameters for deep brain stimulation. Clin Neurophysiol. 2004 Nov;115(11):2431-41. doi: 10.1016/j.clinph.2004.05.031.
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)
November 11, 2025
Primary Completion (Estimated)
October 11, 2029
Study Completion (Estimated)
November 11, 2029
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)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 857667
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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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