Non-Invasive Bioelectronic Analytics

NCT04100486 | Enrolling By Invitation FDA Device

• 1 other identifier: 19-0461
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autonomic Dysfunction; Autonomic Imbalance; Autonomic Nervous System Diseases; Vagus Nerve Autonomic Disorder

Keywords

Vagus Nerve Stimulation; Noninvasive; Autonomic Nervous System; Biosensors; Vitals Monitoring; Machine Learning; Deep Learning

Outcome Measures

Primary Outcomes (7)

• Changes in Heart Rate (Electrocardiography) related to Autonomic Nervous System Perturbations

  The primary objective is to measure changes in ANS balance in healthy able-bodied individuals by discovering a multi-modal index to quantify the activation status of the sympathetic and parasympathetic nervous systems during a battery of clinically relevant tasks. Changes in electrocardiography (EKG) signals will be measured to measure heart rates while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. Heart rates will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  4 2-hour sessions over 2 weeks

• Changes in Brain Activity (Electroencephalography) related to Autonomic Nervous System Perturbations

  Changes in electroencephalography (EEG) signals by a dry and noninvasive electrode cap will be measured to measure brain activity while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. EEG activity will be analyzed by measuring changes in power in specific frequency bands (delta, theta, alpha, beta, and gamma). Brain activity will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  4 2-hour sessions over 2 weeks

• Changes in Respiratory Rate related to Autonomic Nervous System Perturbations

  Changes in respiratory rate will be measured by a belt while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. The belt stretches and relaxes during inspiration (inhalation) and expiration (exhalation), respectively, to infer respiration rate. Respiration changes will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  4 2-hour sessions over 2 weeks

• Changes in Sweat Gland Activity (Galvanic Skin Response) related to Autonomic Nervous System Perturbations

  Changes in sweat gland activity will be measured by dry metal electrodes on two fingers while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. The electrodes measure the galvanic skin response (GSR), a measure of electrical activity that changes depends on the sweat response. Sweat responses will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  4 2-hour sessions over 2 weeks

• Changes in Blood Pressure related to Autonomic Nervous System Perturbations

  Changes in blood pressure will be measured by an inflatable cuff on one finger while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. A wrist device is placed with a Velcro strap on the wrist to provide air and power for the finger cuff to inflate and deflate with changes in blood pressure. Blood pressure will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  4 2-hour sessions over 2 weeks

• Changes in Skin Temperature related to Autonomic Nervous System Perturbations

  Changes in skin temperature will be measured by a circular probe (smaller than a dime) placed on the skin while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. Temperature will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  4 2-hour sessions over 2 weeks

• Changes in Pupil Size related to Autonomic Nervous System Perturbations

  Changes in pupil size will be measured by eye tracking glasses while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. The glasses are easily wearable and mobile glasses with multiple small cameras to track gaze and pupil size. Pupil sizes will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  4 2-hour sessions over 2 weeks

Secondary Outcomes (7)

• Changes in Heart Rate (Electrocardiography) due to taVNS

  4 2-hour sessions over 2 weeks

• Changes in Brain Activity (Electroencephalography) due to taVNS

  4 2-hour sessions over 2 weeks

• Changes in Respiratory Rate due to taVNS

  4 2-hour sessions over 2 weeks

• Changes in Sweat Gland Activity (Galvanic Skin Response) due to taVNS

  4 2-hour sessions over 2 weeks

• Changes in Blood Pressure due to taVNS

  4 2-hour sessions over 2 weeks

Study Arms (1)

Healthy, Able-Bodied Individuals

This study will only enroll healthy, able-bodied individuals.

Other: Standing-Squatting-Standing Test; Other: Deep Breathing Test; Other: Cold Pressor Test; Other: Cold Face Test; Other: Valsalva Maneuver; Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Interventions

Standing-Squatting-Standing Test OTHER

The participant will begin by actively standing for one minute, followed by a transition to a squat for one minute, and one last transition to one minute of standing.

Healthy, Able-Bodied Individuals

Deep Breathing Test OTHER

The participant will be asked to lay down for seven minutes and take long, controlled breaths at a rate within 4 to 10 breaths per minute.

Healthy, Able-Bodied Individuals

Cold Pressor Test OTHER

The participant will be asked to immerse their hand into ice water (1- 10°C) for up to three minutes, followed by removal of the hand from the bath and continuation for recording for a further three to five minutes. The participant will be informed that he or she can remove his or her hand at any point if there is discomfort.

Healthy, Able-Bodied Individuals

Cold Face Test OTHER

The cold stimulus will be applied with refrigerated gel-filled compresses places on the forehead and cheeks of the participant for one minute.

Also known as: Diving Reflex Text

Healthy, Able-Bodied Individuals

Valsalva Maneuver OTHER

The participant will be asked to inhale deeply, pinch his or her nose, close his or her mouth, and forcibly exhale, while bearing down with tight chest and stomach muscles, for approximately 10 to 15 seconds. The sensors will continue recording as the participant recovers to normal breathing over the next one minute.

Healthy, Able-Bodied Individuals

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) DEVICE

The participant will receive electrical stimulation applied to their ear for five minutes. The threshold for stimulation will be determined before the test begins at a level that may elicit sensation (tickling, vibrating, pricking), but no pain. There is a possibility that the participant will receive sham stimulation, or inactive stimulation, for this test.

Also known as: Noninvasive Vagus Nerve Stimulation at the Ear

Healthy, Able-Bodied Individuals

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will only enroll healthy able-bodied individuals. To be eligible to participate in this study, individuals must be between the ages of 18 and 60 years (to avoid changes in ANS with age), proficient in English, BMI less than 30 based on height and weight, and able and willing to provide informed consent and comply with the requirement of the study protocol.

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

The Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location

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MeSH Terms

Conditions

Primary Dysautonomias; Autonomic Nervous System Diseases

Interventions

Valsalva Maneuver

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Respiratory Physiological Phenomena

Study Officials

• Theodoros P Zanos, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neural and Data Science Laboratory

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 24, 2019
• Study Start: August 29, 2019
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)