Non-invasive trigeminal nerve stimulation to improve brain fluid flow and slow cognitive decline

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional feasibility trial applies mild, non-invasive stimulation to the trigeminal nerve (V1) while measuring changes in cerebral blood flow and cerebrospinal fluid dynamics. Approximately 20 cognitively healthy adults and a cohort of participants 1–52 weeks after a diagnosed mild traumatic brain injury will receive intermittent V1 stimulation with simultaneous fNIRS and MRI, including sessions in the MAGNUS scanner. The study tests whether restoring blood flow via trigeminal stimulation can increase CSF influx into the brain parenchyma and facilitate clearance of metabolic waste implicated in post-concussion symptoms and neurodegenerative processes. Primary outcomes are imaging-based measures of blood and CSF flow, along with feasibility and safety signals for using this non-invasive approach in a clinical population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Wisconsin - Madison
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Kip Ludwig, PhD — University of Wisconsin, Madison
• Study coordinator: Neurosurgery Research
• Email: research@neurosurgery.wisc.edu
• Phone: 608-261-1577

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.