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

April 3, 2026 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • UW School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Volunteers
Participants undergo TMS-EEG recordings during wakefulness and sleep to assess brain complexity and consciousness state
Device: TMS combined with EEG
Structural MRI is used to help determine coil placement, before TMS-EEG visit.
Other Names:
  • Transcranial magnetic stimulation (TMS)
  • electroencephalography (EEG)
Device: Presence-IP1.0
novel algorithm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Presence-IP1.0
Time Frame: data collected during experimental sessions (2 visits, up to 8 hours each)

Sensitivity will refer to TP/(TP+FN)

Where TP is Presence-IP1.0 correctly diagnosing consciousness and FN is Presence-IP1.0 falsely diagnosing unconsciousness.
data collected during experimental sessions (2 visits, up to 8 hours each)
Specificity of Presence-IP1.0
Time Frame: data collected during experimental sessions (2 visits, up to 8 hours each)

Specificity is TN/(TN+FP)

Where TN is Presence-IP1.0 correctly diagnosing unconsciousness and FP is Presence-IP1.0 falsely diagnosing consciousness.
data collected during experimental sessions (2 visits, up to 8 hours each)
Signal to Noise Ratio
Time Frame: data collected during experimental sessions (2 visits, up to 8 hours each)
To assess the signal quality of reduced EEG montage, the signal-to-noise ratio will be reported.
data collected during experimental sessions (2 visits, up to 8 hours each)
Stability of TMS-evoked responses
Time Frame: data collected during experimental sessions (2 visits, up to 8 hours each)
To assess the signal quality of reduced EEG montage, the stability of TMS-evoked responses will be reported. This refers to the reproducibility of the TMS response components across the first vs the second half of stimulation runs.
data collected during experimental sessions (2 visits, up to 8 hours each)
Agreement with standard high-density EEG metrics (if available
Time Frame: data collected during experimental sessions (2 visits, up to 8 hours each)
Comparison of average performance of PresenceIP1.0 on the lower-density EEG dataset acquired to this study compared to a reference, previously acquired high-density EEG dataset.
data collected during experimental sessions (2 visits, up to 8 hours each)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
Intrinsic Powers, Inc

Investigators

  • Principal Investigator: Melanie Boly, MD, PhD, UW School of Medicine and Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0320
  • SMPH | NRL Neurology (Other Identifier: UW Madison)
  • Protocol Version: 3/05/2026 (Other Identifier: UW Madison)
  • 1R41NS137850 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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