NCT07523191 · University of Wisconsin, Madison
Validation of Presence-IP1.0 for Detection of Consciousness Using Reduced-Montage TMS-EEG
What this study is about
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.
View original scientific description
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)
Area under the receiver operating characteristic curve (AUC) for discriminating conscious versus unconscious states using Presence-IP1.0
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Madison, Wisconsin
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Intrinsic Powers, Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations