What side effects are associated with this type of intervention?

Common treatments for motion sickness, particularly those involving gradual exposure and adaptation techniques like the self-administered rehabilitation tool, generally have minimal side effects. These methods aim to incrementally increase head motion to help the body adapt, which may cause temporary discomfort or dizziness during the initial stages. Other common treatments, such as medications (e.g., antihistamines like dimenhydrinate or meclizine), can cause drowsiness, dry mouth, and blurred vision. Non-pharmacological approaches like acupressure bands are typically well-tolerated but may cause mild skin irritation.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of motion sickness, including scopolamine (Transderm Scop), which is available as a transdermal patch, and antihistamines such as dimenhydrinate (Dramamine) and meclizine (Bonine). These medications work by blocking certain signals in the brain that trigger nausea and vomiting. While the self-administered rehabilitation tool involving incremental head motion is a novel approach, traditional treatments have primarily focused on pharmacological interventions rather than rehabilitative techniques.

What other types of research exist?

Promising novel alternatives for motion sickness treatment include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing pain intensity in migraine patients and could potentially be adapted for motion sickness. 2) Remote electrical neuromodulation, which uses a device controlled by a smartphone to apply nonpainful electrical skin stimulation and has been effective in reducing acute migraine pain. These methods offer non-invasive, drug-free options that could be beneficial for motion sickness patients.

← Back to Search

Procedure

SWAN Therapy for Vestibular Disorders (SWAN Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for motion sickness include antihistamines, anticholinergics, and vestibular rehabilitation exercises. Antihistamines, such as dimenhydrinate, work by blocking histamine receptors in the brain, which helps reduce nausea and vomiting. Anticholinergics, like scopolamine, inhibit the action of acetylcholine, a neurotransmitter involved in motion sickness, thereby reducing symptoms. Vestibular rehabilitation exercises, including the self-administered rehabilitation tool studied in the trial, aim to desensitize the vestibular system by gradually increasing head motion. This incremental exposure helps the brain adapt to motion stimuli, reducing the severity of motion sickness. These treatments are crucial for patients as they target the underlying mechanisms of motion sickness, providing relief and improving their ability to engage in daily activities without discomfort.

N/A

Recruiting

Led By Matthew Stewart, MD PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

In good general health as evidenced by medical history or diagnosed with unilateral vestibular schwannoma

Be older than 18 years old

Must not have

Current use of anti-nausea medication

Presence of cervical spine pathology that limits head motion to < 30 degrees in the horizontal or vertical plane (i.e. degenerative disc disease, rheumatoid arthritis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily for up to 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device that helps patients practice head movements to reduce motion sickness and improve balance after certain surgeries. It is aimed at patients who have undergone specific surgeries and experience motion sickness and balance problems. The device guides head movements and monitors for nausea to help patients gradually get used to motion.

Who is the study for?

This trial is for people in good health or with unilateral vestibular schwannoma, who can follow the SWAN/vestibular rehab regimen and commit to the study's duration. It excludes those on anti-nausea meds, recent motion sickness treatments, legally blind individuals, or those with neck/spine issues limiting head movement.

What is being tested?

The trial tests a self-help tool called SWAN against traditional therapy. It aims to reduce motion sickness and improve balance after certain surgeries by training users to gradually increase head movements.

What are the potential side effects?

While specific side effects are not listed, this type of physical rehabilitation may cause temporary discomfort, dizziness or nausea as participants adjust their head movements during exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am generally healthy or have a unilateral vestibular schwannoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking medication for nausea.

Select...

I have a neck condition that limits my head movement.

Select...

I cannot walk or stand on my own due to a recent surgery or bone condition.

Select...

I haven't used any experimental drugs or methods for motion sickness in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily for up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily for up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily for up to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Motion sickness intensity as assessed by subjective rating

Secondary study objectives

Change in Daily Activity as assessed by an activity monitor

Change in Foam Stance - Eyes Closed

Change in Foam Stance - Eyes Closed with head motion

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: SWAN VPT JHUExperimental Treatment1 Intervention

Subjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method

Group II: SWAN Motion Sick DaytonExperimental Treatment1 Intervention

Healthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness.

Group III: Traditional VPT JHUActive Control1 Intervention

Subjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site.

Group IV: Traditional Motion Sick DaytonActive Control1 Intervention

Typically, the suggestion for treating motion sickness once it has started is to avoid motion. Therefore, healthy control subjects that meet similar similar physical characteristics of astronauts will not receive any post motion sickness treatment.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for motion sickness include antihistamines, anticholinergics, and vestibular rehabilitation exercises. Antihistamines, such as dimenhydrinate, work by blocking histamine receptors in the brain, which helps reduce nausea and vomiting. Anticholinergics, like scopolamine, inhibit the action of acetylcholine, a neurotransmitter involved in motion sickness, thereby reducing symptoms. Vestibular rehabilitation exercises, including the self-administered rehabilitation tool studied in the trial, aim to desensitize the vestibular system by gradually increasing head motion. This incremental exposure helps the brain adapt to motion stimuli, reducing the severity of motion sickness. These treatments are crucial for patients as they target the underlying mechanisms of motion sickness, providing relief and improving their ability to engage in daily activities without discomfort.

Is vestibular rehabilitation effective in improving dizziness and function after unilateral peripheral vestibular hypofunction? An abridged version of a Cochrane Review.