Non-Invasive Bioelectronic Analytics
Enrolling by invitation · Has a placebo group
Conditions studied: Autonomic Dysfunction, Autonomic Imbalance, Autonomic Nervous System Diseases, Vagus Nerve Autonomic Disorder
In brief
Biomarkers can be evaluated to provide information about disease presence or intensity and treatment efficacy. By recording these biomarkers through noninvasive clinical techniques, it is possible to gain information about the autonomic nervous system (ANS), which involuntarily regulates and adapts organ systems in the body. Machine learning and signal processing methods have made it possible to quantify the behavior of the ANS by statistically analyzing recorded signals. This work will aim to systematically measure ANS function by multiple modalities and use decoding algorithms to derive an index that reflects overall ANS function and/or balance in healthy able-bodied individuals. Additionally, this study will determine how transcutaneous auricular vagus nerve stimulation (taVNS), a noninvasive method of stimulating the vagus nerve without surgery, affects the ANS function. Data from this research will enable the possibility of detecting early and significant changes in ANS from "normal" homeostasis to diagnose disease onset and assess severity to improve treatment protocols.
Key facts
- Study ID
- NCT04100486
- Run by
- Northwell Health
- People needed
- 48
- Starts
- 2019-08-29
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Individuals between 18-60 years of age (to avoid changes in ANS with age)
- Individuals that are considered English Proficient due to the study requirements to follow verbal commands
- Able-bodied persons with no known health conditions
- BMI < 30.0, based on height and weight (to limit known effects of high BMI on ANS activity [Costa et al., 2019])
- Able and willing to give written informed consent and comply with the requirements of the study protocol
You may not qualify if…
- History of any of the following: cardiac arrhythmia, coronary artery disease, autoimmune disease, chronic inflammatory disease, anemia, malignancy, depression, neurologic disease, diabetes mellitus, renal disease, dementia, psychiatric illness including active psychosis, or any other chronic medical condition
- Evidence of active infection
- Family history of inflammatory disease
- Treatment with an anti-cholinergic medication, including over-the-counter medications for allergy and sleep-aid within the past 1 week, including all drugs with Amitriptyline, Atropine, Benztropine, Chlorpheniramine, Chlorpromazine, Clomipramine, Clozapine, Cyclobenzaprine, Cyproheptadine, Desipramine, Dexchlorpheniramine, Dicyclomine, Diphenhydramine (Benadryl), Doxepin, Fesoterodine, Hydroxyzine, Hyoscyamine, Imipramine, Meclizine, Nortriptyline, Olanzapine, Orphenadrine, Oxybutynin, Paroxetine, Perphenazine, Prochlorperazine, Promethazine, Protriptyline, Pseudoephedrine, Scopolamine, Thioridazine, Tolterodine, Trifluoperazine, and Trimipramine
- Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants, deep brain stimulators, or vagus nerve stimulators
- Current tobacco or nicotine use (to limit any potentially confounding effects of exposure to nicotine), which includes any use within the past 1 week
- Chronic inflammatory disorders
- Pre-existing neurological disease, which indicates any significant neurological condition, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's Disease, or stroke
- Pregnancy or lactation (determined by self-report), as early pregnancy may potentially impact ANS measurements
- Active ear infection (otitis media or externa) or any other afflictions of the ear
- Any condition that, in the investigator's opinion, would jeopardize the participant's safety following exposure to a study intervention
- Inability to comply with study procedures and methods
- Prisoners
Where it is running
- The Feinstein Institutes for Medical Research — Manhasset, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.