Recruiting

Presence-IP1.0

Sponsor:

University of Wisconsin, Madison

Code:

NCT07523191

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

TMS combined with EEG

Presence-IP1.0

Study Details

Brief 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

Study ID

NCT07523191

Start date

Mar 18, 2026

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteers

Participants undergo TMS-EEG recordings during wakefulness and sleep to assess brain complexity and consciousness state

Interventions

TMS combined with EEG

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

Presence-IP1.0

novel algorithm

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Melanie Boly, MD, PhD

608-263-4338boly@neurology.wisc.edu

Urszula Gorska, PhD

gorska@wisc.edu

Locations

UW School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • TMS-EEG
  • consciousness
  • complexity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-04-13.