Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A535700 | Other Identifier | UW Madison | |
| Protocol Version 3/31/26 | Other Identifier | UW Madison | |
| SMPH/NEURO SURG/NEURO SURG | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Neuraworx Medical Technologies | UNKNOWN |
Not provided
Not provided
Not provided
The purpose of this research is to demonstrate that mild stimulation of a nerve (trigeminal nerve) in the head can modulate blood flow in the brain. The modulated blood flow will restore the flow of cerebrospinal fluid (CSF) and this in turn can help improve waste clearance in the brain and prevent build up that may lead to disease.
The goal of this clinical trial is to demonstrate that non-invasive stimulation of the trigeminal nerve can be used to restore blood flow and consequently modulate CSF flow into the brain parenchyma to facilitate brain waste clearance that is impaired in patients with AD. This study will collect brain MRI data on 20 healthy cognitively unimpaired adults receiving intermittent trigeminal nerve branch (V1) stimulation. Participants with recent mild traumatic brain injuries will also be enrolled to establish feasibility within a clinically relevant population.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Active Comparator |
| |
| Mild traumatic brain injury (mTBI) | Active Comparator | Participants with recent mTBI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional near-infrared spectroscopy (fNIRS) | Device | fNIRS is a non-invasive imaging technique which takes advantage of the light scattering and absorption differences between oxygenated (HbO) and de-oxygenated hemoglobin (HbDO) to characterize changes in cerebral hemodynamics in response to a given task or stimulus. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood flow through the brain parenchyma - fNIRS | The fNIRS device will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation. | Baseline to 4 hours |
| Change in blood flow through the brain - MRI | The MRI will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation. | Baseline to 90 minutes |
| Change in cerebrospinal fluid flow | MRI scan will be used to measure the flow of cerebrospinal fluid before, during and after stimulation. | Baseline to 90 minutes |
Not provided
Not provided
Inclusion Criteria - Healthy Participants :
Inclusion Criteria - mTBI :
Exclusion Criteria - Healthy Participants:
Exclusion Criteria - mTBI:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neurosurgery Research | Contact | 608-261-1577 | research@neurosurgery.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kip Ludwig, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Recruiting | Madison | Wisconsin | 53705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| V1 stimulation electrodes | Device | The V1 electrodes will be placed on the forehead with some gel and held in place with a headband or cap (a conductive adhesive gel may be placed under the electrodes to help with stimulation). Participants will receive short electrical stimulations through these electrodes that will differ in intensity. |
|
| Magnetic Resonance Imaging (MRI) | Device | Participants will undergo 2 90-minute MRI sessions |
|
| MAGNUS scanner | Device | Simultaneous Coherent-Incoherent Motion Imaging (SCIMI) available on the MAGNUS scanner will be used to perform quality control and optimization in healthy volunteers, to better resolve and visualize slow CSF flows within the brain. |
|
|
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
Not provided
Not provided
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided