University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
Location status: Recruiting
Location contact
Kip Ludwig, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07044596
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.
Interested in participating?
Request Info20 year–85 year
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
Location status: Recruiting
Kip Ludwig, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy Participants :
Inclusion criteria
- mTBI :
Exclusion criteria
- Healthy Participants:
Exclusion criteria
- mTBI:
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.
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.
Participants will undergo 2 90-minute MRI sessions
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.
Other names: GE-MAGNUS 3T MRI scanner
Time frame: Baseline to 4 hours
The fNIRS device will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation.
Time frame: Baseline to 90 minutes
The MRI will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation.
Time frame: Baseline to 90 minutes
MRI scan will be used to measure the flow of cerebrospinal fluid before, during and after stimulation.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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