Neurostimulation Device for Motion Sickness

Recruiting in Palo Alto (17 mi)

Overseen byIsaac D Erbele, MD, ENT

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: 59th Medical Wing

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this research study is to learn how a wearable nerve stimulation device, the Spark Biomedical's Sparrow Ascent System™, impacts the development of spatial disorientation and/or motion sickness in a healthy population. Spatial disorientation is when there is a "mismatch" between where a person is, and where the sense organs in their body tell them where they are. These sense organs include the inner ear (the vestibular system), the eyes (the visual system), the sense of where one's legs, back, and neck are (proprioceptive system), and one's higher thinking (cognitive centers). If spatial disorientation is severe or occurs in motion-naïve individuals, spatial disorientation can lead to motion sickness. The Sparrow Ascent System™ is a wearable, battery-operated transcutaneous auricular (ear) neurostimulation (tAN) device. This means that it uses electrical pulses to stimulate branches of nerves on and/or around the ear, specifically the "vagus" and "trigeminal" nerves. These nerves are also responsible for your sensation of nausea and your heart rate (vagus nerve), as well as headaches (trigeminal nerve). The Sparrow System utilizes a flexible earpiece with embedded hydrogel electrodes that stick to the skin, the earpiece is disposable after use. This device is already Food and Drug Administration (FDA) approved for use in humans and is safely used for control of symptoms in a variety of other medical conditions, such as opioid withdrawal and acute stress reaction. In this study, we will determine if the Sparrow Ascent System™ impacts the development of spatial disorientation or motion sickness.

Eligibility Criteria

This trial is for healthy individuals to see if a wearable device, the Sparrow Ascent System™, can reduce feelings of disorientation and motion sickness. Participants should not have any health issues that could interfere with the study or make using the device unsafe.

Inclusion Criteria

Participants who are able to read and understand study procedures in order to provide informed consent

I am between 18-50, healthy, not pregnant, and don't get motion sickness.

I speak English.

Exclusion Criteria

I have neck pain or a spine condition.

Recently ill or hospitalized within 30 days

Pilots and individuals formally desensitized to motion sickness

+12 more

Participant Groups

The study tests how effective the Sparrow Ascent System™, a nerve stimulation device worn on the ear, is at preventing spatial disorientation and motion sickness by sending electrical pulses to certain nerves.

2Treatment groups

Active Control

Group I: Sham Transcutaneous Auricular Neurostimulation Device (Group 2)Active Control1 Intervention

The Sparrow Ascent Clinical Tool will be used to designate the tAN device as either active or sham. For participants randomized to the sham tAN group (Group 2), the Sparrow Ascent device will be programmed to sham settings. The participant receives a device that is turned on at the time of earpiece placement but does not provide electric stimulation. The subjects will remain blinded to their group assignment. At each interaction with the subject, the research coordinator will inform the subject that the device may be activated, and they may or may not feel stimulation at the time of activation. Subjects will then undergo spatial disorientation and motion sickness challenges. Vital signs will be obtained at specific time markers, and questionnaires and assessments completed.

Group II: Active Transcutaneous Auricular Neurostimulator Device (Group 1)Active Control1 Intervention

The Sparrow Ascent Clinical Tool will be used to designate the tAN device as either active or sham. For participants randomized to the active tAN group (Group 1), the Sparrow Ascent device will be programmed to the preset stimulation parameters. If the participant states that the stimulation intensity is discomforting, the research coordinator will gradually decrease/increase until a comfortable stimulation intensity is achieved. After the device is programmed, participants' stimulation amplitude (in mA) will be documented. The subjects will remain blinded to their group assignment. At each interaction with the subject, the research coordinator will inform the subject that the device may be activated, and they may or may not feel stimulation at the time of activation. Subjects will then undergo spatial disorientation and motion sickness challenges. Vital signs will be obtained at specific time markers, and questionnaires and assessments completed.