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Search / Trial NCT07044596

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

Launched by UNIVERSITY OF WISCONSIN, MADISON · Jun 23, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new, gentle way to stimulate a nerve in the head called the trigeminal nerve, with the goal of improving blood and fluid flow in the brain. By doing this, researchers hope to help the brain clear out waste more effectively, which could slow down memory and thinking problems that sometimes happen after a mild traumatic brain injury (like a concussion). This could potentially help people recover better after such injuries.

The study is looking for adults between 20 and 85 years old, including both healthy individuals and those who have had a mild traumatic brain injury within the past year. Participants should be willing and able to complete all parts of the study, and those with certain medical conditions or who take specific medications may not be eligible. If you join, you can expect to undergo non-invasive procedures involving mild nerve stimulation and brain imaging tests. The study is not yet recruiting, but it aims to better understand if this gentle nerve stimulation can support brain health after injury.

Gender

ALL

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

About University Of Wisconsin, Madison

The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.

Locations

Madison, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Kip Ludwig, PhD

Principal Investigator

University of Wisconsin, Madison

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported