Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT07044596

Conditions

Mild Traumatic Brain Injury

Post Concussion Syndrome

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Functional near-infrared spectroscopy (fNIRS)

V1 stimulation electrodes

Magnetic Resonance Imaging (MRI)

MAGNUS scanner

Study Details

Brief 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

Study ID

NCT07044596

Start date

Nov 13, 2025

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria - Healthy Participants :

  • 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

Inclusion Criteria - mTBI :

  • 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 Criteria - Healthy Participants:

  • Contraindication to MRI
  • Known allergies to common electrode materials

Exclusion Criteria - mTBI:

  • 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

Study Design

Enrollment

55 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Healthy Controls

active comparator: Mild traumatic brain injury (mTBI)

Participants with recent mTBI

Interventions

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.

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.

Magnetic Resonance Imaging (MRI)

Participants will undergo 2 90-minute MRI sessions

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.

Primary outcome measure

  • Change in blood flow through the brain parenchyma - fNIRS [ Time Frame: Baseline to 4 hours ]
  • Change in blood flow through the brain - MRI [ Time Frame: Baseline to 90 minutes ]
  • Change in cerebrospinal fluid flow [ Time Frame: Baseline to 90 minutes ]

Central Contacts and Locations

Central contacts

Neurosurgery Research

608-261-1577research@neurosurgery.wisc.edu

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator:

Kip Ludwig, PhD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-05-06.