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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07044596
Status
Recruiting
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Conditions

  • Mild Traumatic Brain Injury
  • Post Concussion Syndrome

Eligibility Criteria

Sex
ALL
Age
20 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Functional near-infrared spectroscopy (fNIRS) — DEVICE
    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.
  • V1 stimulation electrodes — DEVICE
    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.
  • Magnetic Resonance Imaging (MRI) — DEVICE
    Participants will undergo 2 90-minute MRI sessions
  • MAGNUS scanner — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 13, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Healthy Controls
  • Active Comparator: Mild traumatic brain injury (mTBI)
    Participants with recent mTBI

Primary Outcome Measure

Change in blood flow through the brain parenchyma - fNIRS [ Time Frame: Baseline to 4 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin - MadisonMadisonWisconsin53705
Kip Ludwig, PhD (PRINCIPAL_INVESTIGATOR)

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University of Wisconsin - Madison· Madison, WI

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