Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
NCT ID: NCT07044596
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
55 participants
INTERVENTIONAL
2025-11-13
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Healthy Controls
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.
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.
Magnetic Resonance Imaging (MRI)
Participants will undergo 2 90-minute MRI sessions
Mild traumatic brain injury (mTBI)
Participants with recent mTBI
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.
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.
Magnetic Resonance Imaging (MRI)
Participants will undergo 2 90-minute MRI sessions
Interventions
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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.
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.
Magnetic Resonance Imaging (MRI)
Participants will undergo 2 90-minute MRI sessions
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Known allergies to common electrode materials
* 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
20 Years
85 Years
ALL
Yes
Sponsors
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Neuraworx Medical Technologies
UNKNOWN
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Kip Ludwig, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin - Madison
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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A535700
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 3/10/25
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/NEURO SURG/NEURO SURG
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0970
Identifier Type: -
Identifier Source: org_study_id
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