Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional near-infrared spectroscopy (fNIRS), V1 stimulation electrodes, Magnetic Resonance Imaging (MRI), MAGNUS scanner.
- Who it may be relevant to
- Registry conditions: Mild Traumatic Brain Injury, Post Concussion Syndrome. Basic parameters: 20 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The goal of this clinical trial is to demonstrate that non-invasive stimulation of the trigeminal nerve can be used to restore blood flow and consequently modulate CSF flow into the brain parenchyma to facilitate brain waste clearance that is impaired in patients with AD. This study will collect brain MRI data on 20 healthy cognitively unimpaired adults receiving intermittent trigeminal nerve branch (V1) stimulation. Participants with recent mild traumatic brain injuries will also be enrolled to establish feasibility within a clinically relevant population.
Interventions
- 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 - 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.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Wisconsin - Madison — Madison
Identifiers
NCT: NCT07044596 · 2023-0970 · A535700 · Protocol Version 3/31/26 · SMPH/NEURO SURG/NEURO SURG