Non-Invasive Bioelectronic Analytics

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

Interventions

OTHER

Standing-Squatting-Standing Test

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.

OTHER

Deep Breathing Test

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.

OTHER

Cold Pressor Test

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.

OTHER

Cold Face Test

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

OTHER

Valsalva Maneuver

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.

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

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.

Sponsors & Collaborators

• Northwell Health

  lead OTHER

Principal Investigators

• Theodoros P Zanos, PhD · Northwell Health

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-29

Primary Completion

2025-06-30

Completion

2025-09-30

FDA Device

Yes

Countries

• United States

Study Locations