NCT07044596 Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
| NCT ID | NCT07044596 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Wisconsin, Madison |
| Condition | Mild Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 55 participants in total. It began in 2025-11-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Kip Ludwig, PhD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT07044596 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 85 Years, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07044596 currently recruiting?
Yes, NCT07044596 is actively recruiting participants. Contact the research team at research@neurosurgery.wisc.edu for enrollment information.
Where is the NCT07044596 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT07044596 clinical trial?
NCT07044596 is sponsored by University of Wisconsin, Madison. The principal investigator is Kip Ludwig, PhD at University of Wisconsin, Madison. The trial plans to enroll 55 participants.