RecruitingNot Applicable

Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline

United States55 participantsStarted 2025-11-13

Plain-language summary

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.

Who can participate

Age range

20 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 : * Age 20-65 * 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 disorder…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing non-invasive stimulation of the glymphatic system — the brain's waste-clearance network — to slow cognitive decline after concussion or mild TBI. Can you explain what the glymphatic system is, whether my specific situation involves this kind of problem, and whether stimulating it makes sense as a next step for me?
2The trial is measuring changes in blood flow and cerebrospinal fluid flow using fNIRS and MRI. What do those imaging procedures involve in terms of time and any discomfort, and are there reasons related to my health history — like any metal implants or claustrophobia — that could make them difficult or unsafe for me?
3This trial is listed as Phase NA, which often means it's a device or non-drug feasibility study rather than a traditional drug trial. What does that mean for how much is already known about the safety and effectiveness of this type of stimulation in people with post-concussion syndrome?
4Since this is focused on slowing cognitive decline after mild TBI or post-concussion syndrome, are there standard treatments or rehabilitation approaches I should try first — or alongside — rather than waiting to see if I might be a fit for this study?
5The trial is actively recruiting right now. What would the realistic time commitment look like for someone participating, including visits, imaging sessions, and follow-up, and how might that fit with my current recovery and daily responsibilities?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in blood flow through the brain parenchyma - fNIRS

Timeframe: Baseline to 4 hours

Change in blood flow through the brain - MRI

Timeframe: Baseline to 90 minutes

Change in cerebrospinal fluid flow

Timeframe: Baseline to 90 minutes

Trial details

NCT IDNCT07044596

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Neurosurgery Research

608-261-1577 research@neurosurgery.wisc.edu

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials