RecruitingNot ApplicableNCT07044596

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

Sponsor

University of Wisconsin, Madison

Enrollment

55 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

Mild Traumatic Brain Injury

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.

Eligibility

Min Age: 20 YearsMax Age: 85 Years

Inclusion Criteria6

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
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 Criteria13

Contraindication to MRI
Known allergies to common electrode materials
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

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Interventions

DEVICEFunctional 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.

DEVICEV1 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.

DEVICEMagnetic Resonance Imaging (MRI)

Participants will undergo 2 90-minute MRI sessions