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

NCT07523191 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-13

No results posted yet for this study

Summary

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

  • Sleep

Interventions

DEVICE

TMS combined with EEG

Structural MRI is used to help determine coil placement, before TMS-EEG visit.

DEVICE

Presence-IP1.0

novel algorithm

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Intrinsic Powers, Inc

    collaborator UNKNOWN

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Melanie Boly, MD, PhD · UW School of Medicine and Public Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2027-04-30
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07523191 on ClinicalTrials.gov