Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT07523191

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

Led by University of Wisconsin, Madison · Updated on 2026-04-13

30

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

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Trial Site Locations

Total: 1 location

1

UW School of Medicine and Public Health

Madison, Wisconsin, United States, 53792

Actively Recruiting

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Research Team

M

Melanie Boly, MD, PhD

CONTACT

U

Urszula Gorska, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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