No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
55 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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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 depr…
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
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