Back to Trials
NCT07044596NARecruitingAccepts Healthy Volunteers

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

University of Wisconsin, Madison

Start Date

11/13/2025

Completion Date

12/1/2026

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 20 years to 85 years

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 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

Interventions

DEVICE

Functional near-infrared spectroscopy (fNIRS)

DEVICE

V1 stimulation electrodes

DEVICE

Magnetic Resonance Imaging (MRI)

DEVICE

MAGNUS scanner

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Mild Traumatic Brain InjuryPost Concussion Syndrome

Locations

University of Wisconsin - Madison

Madison, Wisconsin 53705

United States