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Recruiting NCT07523191

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

No phase Interventional Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TMS combined with EEG, Presence-IP1.0.
Who it may be relevant to
Registry conditions: Sleep. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Primary outcome measures

  • Accuracy of Presence-IP1.0 to classify consciousness state (AUC) [Time frame: data collected during experimental sessions (2 visits, up to 8 hours each)]
Secondary outcome measures (5)
  • Sensitivity of Presence-IP1.0 [Time frame: 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)]
  • Signal to Noise Ratio [Time frame: 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)]
  • Agreement with standard high-density EEG metrics (if available [Time frame: data collected during experimental sessions (2 visits, up to 8 hours each)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • UW School of Medicine and Public Health — Madison

Identifiers

NCT: NCT07523191 · 2018-0320 · Protocol Version: 3/05/2026 · SMPH | NRL Neurology · 1R41NS137850

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗