Detecting consciousness using a small TMS-EEG setup and the Presence-IP1.0 algorithm
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
Run by University of Wisconsin, Madison · NCT07523191 · Data updated 2026-11-12
This project will try the Presence-IP1.0 algorithm with a reduced-channel TMS-EEG setup to see if it can tell when healthy adults are awake and conscious versus asleep.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | March 18, 2026 |
| Main results expected | April 2027 |
| Study ends | May 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07523191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults (≥18) who are healthy, can give informed consent, tolerate TMS and EEG, and can sleep in a laboratory setting without disruptive sleep disorders or disqualifying implants.
✕Probably not a fit
People with neurological or psychiatric disorders, pregnancy, metal implants or implanted medical devices, uncontrolled medical conditions, significant sleep disorders, or inability to sleep in the lab are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Thirty healthy adult participants will undergo TMS-EEG recordings during wakefulness and natural sleep using a reduced electrode montage designed for portability. A real-time algorithm, Presence-IP1.0, will analyze TMS-evoked EEG responses to classify conscious versus unconscious states. Algorithm classifications will be compared against behavioral and physiological measures of state to determine accuracy. The aim is to determine whether a reduced-channel, portable system can achieve clinically useful accuracy for detecting consciousness.
Why it matters
Potential benefit: If successful, this approach could enable faster, portable, noninvasive detection of consciousness to help diagnose and monitor patients with impaired awareness.
How similar studies have gone: Previous TMS-EEG approaches, including perturbational complexity metrics, have distinguished conscious from unconscious states in research, but Presence-IP1.0's reduced-channel, real-time implementation is novel and less tested.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
UW School of Medicine and Public Health
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Melanie Boly, MD, PhD — UW School of Medicine and Public Health
- Study coordinator: Melanie Boly, MD, PhD
- Email: boly@neurology.wisc.edu
- Phone: 608-263-4338
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.