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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version: 3/05/2026 | Other Identifier | UW Madison | |
| SMPH | NRL Neurology | Other Identifier | UW Madison | |
| 1R41NS137850 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Intrinsic Powers, Inc | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Participants undergo TMS-EEG recordings during wakefulness and sleep to assess brain complexity and consciousness state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS combined with EEG | Device | Structural MRI is used to help determine coil placement, before TMS-EEG visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | data collected during experimental sessions (2 visits, up to 8 hours each) |
| Specificity of Presence-IP1.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melanie Boly, MD, PhD | Contact | 608-263-4338 | boly@neurology.wisc.edu | |
| Urszula Gorska, PhD | Contact | gorska@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melanie Boly, MD, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW School of Medicine and Public Health | Recruiting | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| Presence-IP1.0 | Device | novel algorithm |
|
Specificity is TN/(TN+FP) Where TN is Presence-IP1.0 correctly diagnosing unconsciousness and FP is Presence-IP1.0 falsely diagnosing consciousness. |
| 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. | 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. | 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. | data collected during experimental sessions (2 visits, up to 8 hours each) |
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |