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Non-invasive Stimulation for Slowing Cognitive Decline

This study is exploring a new way to help the brain clear out waste, which could potentially slow cognitive decline. Researchers are testing if mild electrical stimulation to a nerve in your head (the trigeminal nerve) can improve blood flow in the brain. They believe this improved blood flow can restore the flow of cerebrospinal fluid (CSF), which helps remove waste. The study will use Functional near-infrared spectroscopy (fNIRS) and Magnetic Resonance Imaging (MRI) to measure changes in blood flow and CSF. They are looking for healthy volunteers between 20 and 85 years old, and also people who have recently experienced a mild traumatic brain injury or post-concussion syndrome. The current status of this study is unclear.

Study design
This interventional study plans to enroll 55 participants, including healthy volunteers and those with mild traumatic brain injury. It will involve collecting brain MRI data.
What's involved
You would undergo two 90-minute MRI sessions. You would also receive short electrical stimulations through electrodes placed on your forehead, and have fNIRS measurements taken.
Compensation
Not stated in the trial record.
Follow-up
Changes in blood flow and cerebrospinal fluid flow will be measured up to 4 hours after baseline for fNIRS, and up to 90 minutes after baseline for MRI.

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NCT07044596

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

Recruiting
NAAges 20–85InterventionalTreatment
University of Wisconsin, Madison
~55 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Functional near-infrared spectroscopy (fNIRS)V1 stimulation electrodesMagnetic Resonance Imaging (MRI)MAGNUS scanner

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in blood flow through the brain parenchyma - fNIRS
Measured over Baseline to 4 hours
+2 more outcomes measured

Conditions

Mild Traumatic Brain Injury
Post Concussion Syndrome

Explore related trials

Postconcussion syndromeTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Kip Ludwig, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Neurosurgery Research
[email protected]
608-261-1577
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Diagnosed with mild traumatic brain injury and be within 1-52 weeks post-injury
Willing and able to undergo all procedures

Exclusion

Contraindication to MRI
Known allergies to common electrode materials
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

What this trial measures

  • Change in blood flow through the brain parenchyma - fNIRSBaseline to 4 hours

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

  • Change in blood flow through the brain - MRIBaseline to 90 minutes

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

  • Change in cerebrospinal fluid flowBaseline to 90 minutes

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