NCT07044596 · University of Wisconsin, Madison
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Functional near-infrared spectroscopy (fNIRS)
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.
DEVICE
V1 stimulation electrodes
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.
DEVICE
Magnetic Resonance Imaging (MRI)
Participants will undergo 2 90-minute MRI sessions
DEVICE
MAGNUS scanner
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.
Primary outcome measures
Change in blood flow through the brain parenchyma - fNIRS
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.
Change in blood flow through the brain - MRI
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.
Change in cerebrospinal fluid flow
Time frame: Baseline to 90 minutes
MRI scan will be used to measure the flow of cerebrospinal fluid before, during and after stimulation.
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 Participants :
- Age 20-85 years
- Willing and able to undergo all procedures
- Free of any neurological (e.g., epilepsy, stroke, Parkinson's, brain tumors, moderate or severe traumatic brain injury), neuropsychiatric (e.g., schizophrenia, substance abuse, clinical depression), or developmental (e.g., autism, ADHD) or any other medical condition at the discretion of the PI and co-investigators Inclusion Criteria - mTBI :
- Diagnosed with mild traumatic brain injury and be within 1-52 weeks post-injury
- Willing and able to undergo all procedures
Exclusion criteria
- - Healthy Participants:
- Contraindication to MRI
- Known allergies to common electrode materials Exclusion Criteria - mTBI:
- Contraindications for MRI
- Known allergies to common electrode materials
- Candidates currently on cardiovascular medications which, in the opinion of the investigators, would introduce a confounding factor to glymphatic system function (i.e. ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers)
- Candidates who have chronic infectious diseases (e.g. hepatitis, HIV, TB)
- Candidates diagnosed with small vessel disease, vascular associated dementia (e.g. VCID), or renal disease
- Candidates retinopathies or neuropathies that, in the opinion of the investigators, would prevent them from being able to complete the study or would introduce a confounding factor to glymphatic system function
- Candidates with neurological disorders other than those attributed to their primary diagnosis (e.g. MS, PD, ALS, AD or other dementia, uncontrolled pain)
- Candidates who have had a penetrating injury, craniotomy (with the exception of a burr hole (trephination) for resolution of acute subdural hematoma), or refractory subdural hematoma
- Candidates with a history of seizures (except those in the acute or post-acute phases and are controlled)
- Candidates who experienced a loss of consciousness greater than 24 hours as a result of their TBI
- Candidates who, in the opinion of the investigators, are unable to feel a sensory referred sensation from the stimulation or successfully complete the electrode placement and testing fNIRs
Where
- Madison, Wisconsin
Collaborators
Neuraworx Medical Technologies
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 May 6, 2026 · Source of record for eligibility and locations