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NCT Number: NCT07523191

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

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.

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Key information

Conditions

Sleep

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TMS combined with EEG

Device

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

Other names: Transcranial magnetic stimulation (TMS), electroencephalography (EEG)

Presence-IP1.0

Device

novel algorithm

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Boly, MD, PhD

CONTACT

[email protected]

608-263-4338

Urszula Gorska, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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