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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the wearable nerve stimulation device, the Sparrow Ascent System™, might help manage spatial disorientation and motion sickness. The device delivers gentle electrical pulses around the ear to target nerves linked to nausea and headaches. Participants will be divided into two groups: one receiving real stimulation and the other receiving a placebo (non-active treatment) for comparison. Ideal participants are healthy adults who do not normally experience motion sickness and can understand and consent to the study's procedures. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new solutions for 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 prior data suggests that this neurostimulation device is safe for humans?

Research has shown that the Sparrow Ascent System™ is generally safe for people. The FDA has already approved this device for treating conditions like opioid withdrawal and acute stress. A review of studies found that using small electrical pulses on the ear, known as transcutaneous auricular stimulation, is safe for clinical use.

The device stimulates certain nerves that affect nausea, heart rate, and headaches. Studies have demonstrated that this type of stimulation can help reduce symptoms of motion sickness. While slight discomfort from the stimulation may occur, the settings can be adjusted for comfort.

Overall, the safety data suggests that this wearable device is well-tolerated when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transcutaneous Auricular Neurostimulation (tAN) device for motion sickness because it offers a non-drug approach to managing symptoms, unlike traditional medications like antihistamines or anticholinergics, which can cause drowsiness or other side effects. The tAN device uses a novel method, delivering mild electrical stimulation to the ear, potentially providing relief without the common side effects associated with oral medications. Additionally, this device allows for adjustable stimulation levels, which can be tailored to individual comfort, offering a more personalized treatment option.

What evidence suggests that this neurostimulation device is effective for motion sickness?

This trial will compare the effectiveness of the Sparrow Ascent System™ in reducing motion sickness symptoms. Participants will be randomized to receive either an active Transcutaneous Auricular Neurostimulation device or a sham device. Research shows that the Sparrow Ascent System™ uses gentle electrical pulses to stimulate nerves around the ear, such as the vagus and trigeminal nerves, which are linked to feelings of nausea and headaches. Studies have shown that stimulating these nerves can help with motion sickness. The FDA has already approved the device for other uses, like managing opioid withdrawal and stress, suggesting it could also effectively control motion sickness. ^{1 3 4 6 7}

Who Is on the Research Team?

Isaac D Erbele, MD, ENT

Principal Investigator

Brooke Army Medical Center

Are You a Good Fit for This Trial?

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

Recently ill or hospitalized within 30 days

Pilots and individuals formally desensitized to motion sickness

I have neck pain or a spine condition.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06892340

Evaluation of a Device to Reduce Motion Sickness and ... In this study, we will determine if the Sparrow Ascent System™ impacts the development of spatial disorientation or motion sickness. Detailed Description. The ...

2. sparkbiomedical.com sparkbiomedical.com/healthcare-providers/neurological-health

A Better Way Forward in Opioid Withdrawal Management The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an ...

3. trialx.com trialx.com/clinical-trials/listings/305788/evaluation-of-a-device-to-reduce-motion-sickness-and-spatial-disorientation/

Evaluation of a Device to Reduce Motion Sickness and ... In this study, we will determine if the Sparrow Ascent System™ impacts the development of spatial disorientation or motion sickness. Description.

4. withpower.com withpower.com/trial/phase-motion-sickness-1-2025-e3cbe

Neurostimulation Device for Motion Sickness Research shows that transauricular electrical stimulation (tES) and transcutaneous auricular vagus nerve stimulation (taVNS) can reduce motion sickness symptoms ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1566070225000803

Symmetric projection attractor reconstruction taVNS improves visually induced motion sickness, behaviorally and physiologically. •. Machine learning reveals taVNS response; this has implications for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9772204/

Safety of transcutaneous auricular vagus nerve stimulation ... This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11531436/

Transcutaneous Auricular Vagus Nerve Stimulation for ... Further, emerging data provide preliminary evidence that vagal stimulation may attenuate motion sickness symptoms (Molefi et al. 2023c). These studies ...