Mild Traumatic Brain Injury, Post Concussion Syndrome
Conditions
Brief summary
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.
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.
Interventions
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.
DEVICEV1 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.
DEVICEMagnetic Resonance Imaging (MRI)
Participants will undergo 2 90-minute MRI sessions
DEVICEMAGNUS 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.
Sponsors
University of Wisconsin, Madison
Neuraworx Medical Technologies
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood flow through the brain parenchyma - fNIRS | Baseline to 4 hours | The fNIRS device will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation. |
| Change in blood flow through the brain - MRI | Baseline to 90 minutes | The MRI will record changes in the blood oxygen level in the brain that is caused by the V1 stimulation. |
| Change in cerebrospinal fluid flow | Baseline to 90 minutes | MRI scan will be used to measure the flow of cerebrospinal fluid before, during and after stimulation. |
Countries
United States
Contacts
CONTACTNeurosurgery Research
PRINCIPAL_INVESTIGATORKip Ludwig, PhD
University of Wisconsin, Madison
Outcome results
None listed