Study for Detecting Consciousness Using Presence-IP1.0 and TMS-EEG

This study is testing a new computer program called Presence-IP1.0. It works with a brain scanning method called TMS-EEG (Transcranial Magnetic Stimulation combined with Electroencephalography) to see if someone is conscious. We want to see if Presence-IP1.0 can accurately tell if you are awake or asleep using a simpler, more portable system. You can join if you are a healthy adult between 18 and 85 years old, can give your permission to participate, and can sleep in a lab. We are looking for 30 participants. The study will be successful if Presence-IP1.0 can accurately tell the difference between conscious and unconscious states. The current status of this study is unclear.

Study design
This is an interventional study involving 30 healthy adult participants. It is designed to validate a new algorithm for detecting consciousness.
What's involved
You would have two visits, each lasting up to 8 hours. During these visits, you would undergo TMS-EEG recordings while awake and asleep.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during the experimental sessions, which include two visits lasting up to 8 hours each.

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NCT07523191

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

Recruiting
NAAges 18–85InterventionalDiagnostic
University of Wisconsin, Madison
~30 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:TMS combined with EEGPresence-IP1.0

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of Presence-IP1.0 to classify consciousness state (AUC)
Measured over data collected during experimental sessions (2 visits, up to 8 hours each)
Sleep
1 sites across 1 states
Wisconsin1
  • Melanie Boly, MD, PhD · PRINCIPAL_INVESTIGATOR · UW School of Medicine and Public Health

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)
  • Accuracy of Presence-IP1.0 to classify consciousness state (AUC)data collected during experimental sessions (2 visits, up to 8 hours each)

    Area under the receiver operating characteristic curve (AUC) for discriminating conscious versus unconscious states using Presence-IP1.0