SleepNCT07523191
Validation of Presence-IP1.0 for Detection of Consciousness Using Reduced-Montage TMS-EEG
A study testing TMS combined with EEG and Presence-IP1.0 in people with Sleep, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- TMS combined with EEG and Presence-IP1.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Urszula Gorska, PhD contact
United States1 site, 1 recruiting
- Recruiting
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
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
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
- Being tested
- TMS combined with EEG, Presence-IP1.0
- Keywords
- TMS-EEG, consciousness, complexity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS combined with EEGDevice
Also called Transcranial magnetic stimulation (TMS), electroencephalography (EEG)
Structural MRI is used to help determine coil placement, before TMS-EEG visit.
Presence-IP1.0Device
novel algorithm
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Participants undergo TMS-EEG recordings during wakefulness and sleep to assess brain complexity and consciousness state Receives: Device: TMS combined with EEG; Device: Presence-IP1.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: data collected during experimental sessions (2 visits, up to 8 hours each)
Secondary outcomes (5)
Sensitivity of Presence-IP1.0
Sensitivity will refer to TP/(TP+FN)
Where TP is Presence-IP1.0 correctly diagnosing consciousness and FN is Presence-IP1.0 falsely diagnosing unconsciousness.
Measured: data collected during experimental sessions (2 visits, up to 8 hours each)
Specificity of Presence-IP1.0
Specificity is TN/(TN+FP)
Where TN is Presence-IP1.0 correctly diagnosing unconsciousness and FP is Presence-IP1.0 falsely diagnosing consciousness.
Measured: data collected during experimental sessions (2 visits, up to 8 hours each)
Signal to Noise Ratio
To assess the signal quality of reduced EEG montage, the signal-to-noise ratio will be reported.
Measured: data collected during experimental sessions (2 visits, up to 8 hours each)
Stability of TMS-evoked responses
To assess the signal quality of reduced EEG montage, the stability of TMS-evoked responses will be reported. This refers to the reproducibility of the TMS response components across the first vs the second half of stimulation runs.
Measured: data collected during experimental sessions (2 visits, up to 8 hours each)
Agreement with standard high-density EEG metrics (if available
Comparison of average performance of PresenceIP1.0 on the lower-density EEG dataset acquired to this study compared to a reference, previously acquired high-density EEG dataset.
Measured: data collected during experimental sessions (2 visits, up to 8 hours each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start18 Mar 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Intrinsic Powers, Inc
- Responsible party
- Sponsor
- Investigators
- Melanie Boly, MD, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523191
- Sponsor's protocol ID
- 2018-0320
- Other IDs
- Protocol Version: 3/05/2026, SMPH | NRL Neurology, 1R41NS137850
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07523191
- Acronym / sponsor ID
- 2018-0320
- Conditions
- Sleep
- Keywords
- TMS-EEG, consciousness, complexity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Intrinsic Powers, Inc
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: TMS combined with EEG, Device: Presence-IP1.0Participants undergo TMS-EEG recordings during wakefulness and sleep to assess brain complexity and consciousness state |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS combined with EEGAlso: Transcranial magnetic stimulation (TMS), electroencephalography (EEG)Structural MRI is used to help determine coil placement, before TMS-EEG visit. | Device | Healthy Volunteers |
| Presence-IP1.0novel algorithm | Device | Healthy Volunteers |
Primary outcome
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
5 secondary outcomes
Sensitivity of Presence-IP1.0
Time frame: data collected during experimental sessions (2 visits, up to 8 hours each)
Specificity of Presence-IP1.0
Time frame: data collected during experimental sessions (2 visits, up to 8 hours each)
Signal to Noise Ratio
Time frame: data collected during experimental sessions (2 visits, up to 8 hours each)
Stability of TMS-evoked responses
Time frame: data collected during experimental sessions (2 visits, up to 8 hours each)
Agreement with standard high-density EEG metrics (if available
Time frame: data collected during experimental sessions (2 visits, up to 8 hours each)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Urszula Gorska, PhD contact
Melanie Boly, MD, PhD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS combined with EEG and Presence-IP1.0 in people with Sleep, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Boly, MD, PhD (608-263-4338, boly@neurology.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.