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Validation of Presence-IP1.0 for Detection of Consciousness Using Reduced-Montage TMS-EEG

RecruitingNAAges 18 Years - 85 YearsAllUniversity of Wisconsin, Madison
NCT07523191 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to validate a novel real-time algorithm (Presence-IP1.0) designed to detect consciousness from TMS-evoked EEG responses using a reduced electrode montage. Thirty healthy adult participants will undergo TMS-EEG recordings during wakefulness and sleep. The algorithm's ability to differentiate conscious from unconscious states will be evaluated against behavioral and physiological state classification. The goal is to determine whether Presence-IP1.0 achieves clinically useful accuracy for detecting consciousness using a portable, reduced-channel system.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Healthy adults greater than or equal to 18 years * Able to provide informed consent * Able to undergo TMS and EEG recordings * Able to sleep in laboratory setting Exclusion Criteria: * History of neurological or psychiatric disorders * Pregnancy * Sleep disorders affecting normal sleep architecture * Current history of poorly controlled headaches including intractable or poorly controlled migraines * Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) * Possible pregnancy or plan to become pregnant in the next 6 months * Any metal in the head * Any metal in the body * Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD * Dental implants * Permanent retainers * Claustrophobia (a fear of small or closed places) * Back problems that would prevent lying flat for several hours * Regular night-shift work (second or third shift)
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What it tests

  • TMS combined with EEG
  • Presence-IP1.0
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Where

1 site
UW School of Medicine and Public Health
Madison, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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