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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 20 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Healthy Controls
  • Device: Functional near-infrared spectroscopy (fNIRS)
    fNIRS is a non-invasive imaging technique which takes advantage of the light scattering and absorption differences between oxygenated (HbO) and de-oxygenated hemoglobin (HbDO) to characterize changes in cerebral hemodynamics in response to a given task or stimulus.
  • Device: V1 stimulation electrodes
    The V1 electrodes will be placed on the forehead with some gel and held in place with a headband or cap (a conductive adhesive gel may be placed under the electrodes to help with stimulation). Participants will receive short electrical stimulations through these electrodes that will differ in intensity.
  • Device: Magnetic Resonance Imaging (MRI)
    Participants will undergo 2 90-minute MRI sessions
  • Device: MAGNUS scanner
    Simultaneous Coherent-Incoherent Motion Imaging (SCIMI) available on the MAGNUS scanner will be used to perform quality control and optimization in healthy volunteers, to better resolve and visualize slow CSF flows within the brain.
    Other names:
    • GE-MAGNUS 3T MRI scanner
Active Comparator
Mild traumatic brain injury (mTBI) 		Participants with recent mTBI
  • Device: Functional near-infrared spectroscopy (fNIRS)
    fNIRS is a non-invasive imaging technique which takes advantage of the light scattering and absorption differences between oxygenated (HbO) and de-oxygenated hemoglobin (HbDO) to characterize changes in cerebral hemodynamics in response to a given task or stimulus.
  • Device: V1 stimulation electrodes
    The V1 electrodes will be placed on the forehead with some gel and held in place with a headband or cap (a conductive adhesive gel may be placed under the electrodes to help with stimulation). Participants will receive short electrical stimulations through these electrodes that will differ in intensity.
  • Device: Magnetic Resonance Imaging (MRI)
    Participants will undergo 2 90-minute MRI sessions

Recruiting Locations

University of Wisconsin - Madison
Madison, Wisconsin 53705

More Details

Status
Recruiting
Sponsor
University of Wisconsin, Madison

Study Contact

Neurosurgery Research
608-261-1577
research@neurosurgery.wisc.edu

Detailed Description

The goal of this clinical trial is to demonstrate that non-invasive stimulation of the trigeminal nerve can be used to restore blood flow and consequently modulate CSF flow into the brain parenchyma to facilitate brain waste clearance that is impaired in patients with AD. This study will collect brain MRI data on 20 healthy cognitively unimpaired adults receiving intermittent trigeminal nerve branch (V1) stimulation. Participants with recent mild traumatic brain injuries will also be enrolled to establish feasibility within a clinically relevant population.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.