Neurostimulation Device for Motion Sickness

Overseen By Isaac D Erbele, MD, ENT

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: 59th Medical Wing

Must not be taking: Cardiac medications, Vestibular suppressants

Disqualifiers: Pregnancy, Cardiac pathology, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

36 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications that affect the heart, balance, or nervous system, as well as any vestibular suppressing medications or drugs like antihistamines, benzodiazepines, and alcohol within 24 hours of the study.

What data supports the effectiveness of the treatment Transcutaneous Auricular Neurostimulation device for motion sickness?

Research shows that transauricular electrical stimulation (tES) and transcutaneous auricular vagus nerve stimulation (taVNS) can reduce motion sickness symptoms by improving heart rate variability and decreasing certain brain activities, suggesting these treatments can help manage motion sickness without medication. ^{1 2 3 4 5}

Is the Neurostimulation Device for Motion Sickness safe for humans?

The transcutaneous auricular vagus nerve stimulation (taVNS) device, which is similar to the neurostimulation device for motion sickness, is generally considered safe for humans. Most studies report only mild and temporary side effects like ear pain, headache, and tingling, with no severe adverse events linked to its use. ^{1 2 6 7 8}

How does the Transcutaneous Auricular Neurostimulation device treatment for motion sickness differ from other treatments?

The Transcutaneous Auricular Neurostimulation device is unique because it uses a non-invasive method to stimulate the vagus nerve through the ear, which helps reduce motion sickness symptoms without the need for medication. This approach is different from traditional treatments that often rely on drugs, as it modulates brain activity and autonomic function to alleviate symptoms. ^{1 2 3 5 8}

Research Team

Isaac D Erbele, MD, ENT

Principal Investigator

Brooke Army Medical Center

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are exposed to spatial disorientation and motion sickness challenges using a flight simulator and rotating chair, while wearing the Sparrow Ascent System™ or a sham device.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of motion sickness and spatial disorientation symptoms.

90 minutes post-treatment

Treatment Details

Interventions

• Transcutaneous Auricular Neurostimulation device

Trial Overview 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.

Participant Groups

Group I: Sham Transcutaneous Auricular Neurostimulation Device (Group 2) Active Control 1 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 Control 1 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.

Who Is Running the Clinical Trial?

59th Medical Wing

Lead Sponsor

Trials

42

Recruited

12,700+

Defense Health Agency

Collaborator

Trials

3

Recruited

750+

Findings from Research

Transcutaneous electrical acustimulation (TEA) significantly improved tolerance to motion sickness (MS) in healthy participants, with 22 out of 50 completing all five rotations compared to only 11 in the sham group, and it also prolonged the total tolerable rotation time (220.4 seconds vs 173.6 seconds).

TEA reduced MS symptoms and improved gastric function by enhancing vagal activity and suppressing the increase of stress-related hormones like arginine vasopressin and norepinephrine during motion stimulation, indicating its potential as an effective treatment for severe motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acustimulation Ameliorates Motion Sickness Induced by Rotary Chair in Healthy Subjects: A Prospective Randomized Crossover Study. Zhao, Q., Ning, BF., Zhou, JY., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improves depression symptoms, as evidenced by reduced scores on the Hamilton Depression Scale in a review of 12 studies involving 838 participants.

taVNS shows comparable response rates to traditional antidepressants and has fewer side effects, suggesting it could be a safe alternative or complementary treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. Tan, C., Qiao, M., Ma, Y., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

On the potential of transauricular electrical stimulation to reduce visually induced motion sickness. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation towards Visually Induced Motion Sickness Reduction: A Pilot Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acustimulation Ameliorates Motion Sickness Induced by Rotary Chair in Healthy Subjects: A Prospective Randomized Crossover Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical nerve stimulation on motion sickness induced by rotary chair: a crossover study. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

Galvanic vestibular stimulation as a novel treatment for seasickness. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Decreasing motion sickness by mixing different techniques. [2021]