Health TrialsbyHealthPanel

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

ConditionsMild Traumatic Brain InjuryPost Concussion Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-85
SponsorUniversity of Wisconsin, Madison

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Contraindication to MRI

Known allergies to common electrode materials

Contraindications for MRI

Known allergies to common electrode materials

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: Healthy ControlsActive comparator 4 interventions
Group B: Mild traumatic brain injury (mTBI)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in blood flow through the brain parenchyma - fNIRS

The fNIRS device will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation.

Time frame
Baseline to 4 hours
2

Change in blood flow through the brain - MRI

The MRI will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation.

Time frame
Baseline to 90 minutes
3

Change in cerebrospinal fluid flow

MRI scan will be used to measure the flow of cerebrospinal fluid before, during and after stimulation.

Time frame
Baseline to 90 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Neuraworx Medical Technologies

Collaborator

Source ClinicalTrials.gov
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