NCT07044596

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mild Traumatic Brain Injury
• Post Concussion Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-13
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-07-01
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study