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

Prospective Validation of a Reduced-Montage TMS-EEG Complexity Algorithm (Presence-IP1.0) to Differentiate Conscious and Unconscious States Across Wakefulness and Sleep

Who can join

Ages 18 to 85 · All sexes · Healthy volunteers welcome

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)

About the study

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.

What is being tested

• TMS combined with EEG (device)
• Presence-IP1.0 (device)

Sponsor: University of Wisconsin, Madison · Participants: 30 · Started: Mar 18, 2026

Contact the study team

• Melanie Boly, MD, PhD · Phone: 608-263-4338

Official record on ClinicalTrials.gov — NCT07523191

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.