NCT07523191

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026May 2027

Study Start

First participant enrolled

March 18, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 3, 2026

Last Update Submit

April 3, 2026

Conditions

Sleep

Keywords

TMS-EEGconsciousnesscomplexity

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Presence-IP1.0 to classify consciousness state (AUC)

    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 Outcomes (5)

  • Sensitivity of Presence-IP1.0

    data collected during experimental sessions (2 visits, up to 8 hours each)

  • Specificity of Presence-IP1.0

    data collected during experimental sessions (2 visits, up to 8 hours each)

  • Signal to Noise Ratio

    data collected during experimental sessions (2 visits, up to 8 hours each)

  • Stability of TMS-evoked responses

    data collected during experimental sessions (2 visits, up to 8 hours each)

  • Agreement with standard high-density EEG metrics (if available

    data collected during experimental sessions (2 visits, up to 8 hours each)

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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

Device: TMS combined with EEGDevice: Presence-IP1.0

Interventions

TMS combined with EEGDEVICE

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

Also known as: Transcranial magnetic stimulation (TMS), electroencephalography (EEG)
Healthy Volunteers
Presence-IP1.0DEVICE

novel algorithm

Healthy Volunteers

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Interventions

ElectroencephalographyTranscranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetic Field TherapyTherapeutics

Study Officials

  • Melanie Boly, MD, PhD

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Boly, MD, PhD

CONTACT

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

Urszula Gorska, PhD

CONTACT

gorska@wisc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 13, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

US(1)