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

NCT07044596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Mild Traumatic Brain Injury
  • Post Concussion Syndrome

Interventions

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.

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

Sponsors & Collaborators

  • Neuraworx Medical Technologies

    collaborator UNKNOWN

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Kip Ludwig, PhD · University of Wisconsin, Madison

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07044596 on ClinicalTrials.gov