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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07523191
Status
Recruiting
Apply to this trial

Conditions

  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • TMS combined with EEG — DEVICE
    Structural MRI is used to help determine coil placement, before TMS-EEG visit.
  • Presence-IP1.0 — DEVICE
    novel algorithm

Study Details

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.

Key Dates

Start date
Mar 18, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy Volunteers
    Participants undergo TMS-EEG recordings during wakefulness and sleep to assess brain complexity and consciousness state

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UW School of Medicine and Public HealthMadisonWisconsin53792-

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By research site
UW School of Medicine and Public Health· Madison, WI

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