Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
4 other identifiers
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2025
CompletedFirst Posted
Study publicly available on registry
July 1, 2025
CompletedStudy Start
First participant enrolled
November 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 6, 2026
May 1, 2026
1 year
June 23, 2025
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Baseline to 4 hours
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.
Baseline to 90 minutes
Change in cerebrospinal fluid flow
MRI scan will be used to measure the flow of cerebrospinal fluid before, during and after stimulation.
Baseline to 90 minutes
Study Arms (2)
Healthy Controls
ACTIVE COMPARATORMild traumatic brain injury (mTBI)
ACTIVE COMPARATORParticipants with recent mTBI
Interventions
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.
Participants will undergo 2 90-minute MRI sessions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuraworx Medical Technologiescollaborator
- University of Wisconsin, Madisonlead
Study Sites (1)
University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kip Ludwig, PhD
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2025
First Posted
July 1, 2025
Study Start
November 13, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share