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New treatment option for Mild Traumatic Brain Injury
Official title Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
ClinicalTrials.gov ID: NCT07044596
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- mTBI :
You likely can't join if
- 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...
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.