NCT07523191

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

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

Timeline

• Start date: 2026-03-18
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study