SWAN Therapy for Vestibular Disorders

(SWAN Trial)

Recruiting at 2 trial locations

Overseen By Matthew Stewart, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Anti-nausea, Motion sickness

Disqualifiers: Cervical spine pathology, Orthopedic pathology, Legal blindness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to help individuals with balance issues enhance their recovery. It targets those who have undergone surgery affecting their balance nerves or experience motion sickness. Participants will engage in either the new SWAN therapy, a specialized treatment for vestibular disorders, or traditional exercises. The trial seeks individuals who have had this specific surgery or healthy individuals who frequently experience dizziness, similar to astronauts. Those not on anti-nausea medication and able to move their head freely may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially improve balance recovery.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking anti-nausea medications to participate in the trial.

What prior data suggests that this rehabilitation tool is safe for treating vestibular disorders?

Research shows that SWAN therapy, which uses virtual reality to address balance issues, is generally easy for people to manage. Studies have found that side effects, such as nausea or discomfort from the virtual reality experience, are minor for most individuals. This indicates that most people experience no major problems with this treatment.

While specific safety data for SWAN therapy is not available, vestibular rehabilitation therapy, a program of exercises for balance and dizziness, has been used safely for various balance-related conditions. Overall, evidence suggests that SWAN therapy should be quite safe for most people, with only mild side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SWAN Therapy for vestibular disorders because it introduces an automated approach to vestibular rehabilitation. Unlike traditional vestibular physical therapy, which relies on manual exercises at a clinical site, SWAN Therapy uses an automated system, potentially offering more consistent and accessible treatment. This method could be especially beneficial for individuals with vestibular disorders, as it aims to enhance rehabilitation efficiency and effectiveness. Additionally, by studying SWAN Therapy in healthy individuals with motion sickness, researchers hope to uncover new insights into managing vestibular disorders in unique populations, such as astronauts.

What evidence suggests that this trial's treatments could be effective for vestibular disorders?

Research has shown that SWAN Therapy, one of the treatments studied in this trial, might help people regain balance and reduce motion sickness after certain surgeries. Early results suggest that using the SWAN device for head movement practice can improve balance recovery. Another study supports the idea that personalized balance exercises, like those provided by SWAN, help patients with ongoing symptoms after surgeries, such as the removal of a non-cancerous tumor called vestibular schwannoma. These early findings, along with the device's method, offer hope that SWAN Therapy can effectively manage symptoms related to balance disorders. Meanwhile, the trial will also evaluate Traditional Therapy as a comparator to assess its effectiveness in managing similar symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Matthew Stewart, MD PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to follow a specific balance or dizziness treatment plan.

Provision of signed and dated informed consent form

I am generally healthy or have a unilateral vestibular schwannoma.

Exclusion Criteria

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

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

I am currently taking medication for nausea.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform sinusoidal head rotations using a rehabilitation device to mitigate motion sickness and enhance postural recovery

4 weeks

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SWAN
• Traditional Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: SWAN VPT JHU Experimental Treatment 1 Intervention

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

Group II: SWAN Motion Sick Dayton Experimental Treatment 1 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 Vestibular Physical Therapy (VPT) JHU Active Control 1 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 Dayton Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Aeronautics and Space Administration (NASA)

Collaborator

Trials

32

Recruited

1,900+

Published Research Related to This Trial

A four-week home exercise program significantly improved balance performance and reduced self-rated handicap in 16 subjects with chronic vestibular disease, as measured by the Smart Balance Master and Dizziness Handicap Inventory.

While balance and self-rated handicap improved, the emotional aspect of the handicap did not show significant change, suggesting that addressing emotional issues may further enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between change in balance and self-reported handicap after vestibular rehabilitation therapy. Murray, K., Carroll, S., Hill, K.[2019]

Vestibular rehabilitation is an effective exercise-based program that has been shown to improve various symptoms related to vestibular disorders, including imbalance, dizziness, and anxiety, through a process called central compensation.

Recent advancements in techniques such as balance training, gaze stability training, and the use of virtual reality have enhanced the efficacy of vestibular rehabilitation, making it beneficial even for patients with chronic vestibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Vestibular Rehabilitation. Sulway, S., Whitney, SL.[2019]

Vestibular rehabilitation therapy (VRT) is an effective exercise-based treatment that helps improve balance, reduce vertigo, and enhance daily activities for individuals with vestibular disorders, regardless of age or the cause of their symptoms.

Key exercises in VRT focus on head-eye movements and balance tasks, and even short, frequent sessions can significantly aid in vestibular recovery by promoting adaptation and substitution mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy: review of indications, mechanisms, and key exercises. Han, BI., Song, HS., Kim, JS.[2022]

Various medical therapies for dizziness focus on reducing vertigo, managing symptoms, or addressing the underlying causes, with specific medications like antihistamines and calcium channel blockers used for acute peripheral vertigo.

For chronic conditions like Meniere disease, first-line treatments include betahistine and diuretics, while other conditions like vestibular migraine may benefit from antidepressants and calcium channel blockers, highlighting the tailored approach needed for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and Emerging Medical Therapies for Dizziness. Raymond, MJ., Vivas, EX.[2021]

Vestibular physical therapy significantly improved balance and functional outcomes in 48 patients with central vestibular dysfunction, as shown by various assessment measures after an average of 5 therapy visits over 5 months.

Patients with severe disability at baseline experienced greater improvements, although those with cerebellar dysfunction showed the least progress, indicating that the type of vestibular dysfunction may influence therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy for central vestibular dysfunction. Brown, KE., Whitney, SL., Marchetti, GF., et al.[2007]

The study established the minimal clinically important difference (MCID) for the Activities-specific Balance Confidence Scale (ABC), Functional Gait Assessment (FGA), and Gait Speed (GS) in individuals with vestibular disorders, with values of 18.1%, 4 points, and 0.09 m/s respectively, based on a sample of 222 to 237 subjects.

These MCID values, derived using an anchor-based approach with the Dizziness Handicap Inventory (DHI) as a reference, provide important benchmarks for assessing meaningful improvements in gait and balance following vestibular rehabilitation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating the minimal clinically important difference for balance and gait outcome measures in individuals with vestibular disorders. Wellons, RD., Duhe, SE., MacDowell, SG., et al.[2022]

Supervised vestibular rehabilitation treatment programs generally show better outcomes in improving emotional status, dizziness, and balance in individuals with unilateral vestibular disorders, based on a systematic review of six randomized control trials.

However, the review did not find strong evidence that supervised programs are significantly superior to unsupervised or home-based training, highlighting limitations in the self-reported measures used in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Supervision in Vestibular Rehabilitation in Patients with Acute or Chronic Unilateral Vestibular Dysfunction: A Systematic Review. Lilios, A., Chimona, T., Nikitas, C., et al.[2023]

In a study of 2,374 patients with various vestibular disorders, including benign paroxysmal positional vertigo (BPPV) and Menière's disease, it was found that many patients underwent multiple diagnostic tests (average of 3.2) and therapies (average of 1.8), indicating a complex management process for dizziness in primary care.

The study highlights a significant issue in primary care, where 61.3% of patients had more than two consultations, suggesting a need for better training in diagnosing and managing vestibular disorders to prevent misdiagnosis and prolonged treatment delays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health services utilization of patients with vertigo in primary care: a retrospective cohort study. Grill, E., Strupp, M., Müller, M., et al.[2022]

Vestibular physical therapy (VPT) is an evidence-based treatment aimed at reducing symptoms like vertigo, dizziness, and imbalance, which can significantly improve patients' quality of life.

The therapy emphasizes patient safety and includes fall risk assessments to prevent falls, making it a comprehensive approach to managing vestibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular Physical Therapy and Fall Risk Assessment. Carender, WJ., Grzesiak, M., Telian, SA.[2021]

In a study of 80 patients undergoing vestibular assessment, 16% reported using complementary therapies, with Ginkgo biloba and acupuncture being the most common choices.

Nearly half of the patients who tried these therapies (46%) felt that they were helpful, highlighting the importance for clinicians to consider potential interactions between complementary therapies and conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of complementary therapy use in patients undergoing vestibular assessment. Baguley, DM., Humphriss, RL., Butler, K., et al.[2015]

In a study of 2272 patients with peripheral vestibular vertigo, the combination of betahistine and piracetam showed greater improvements in dizziness-related disability compared to betahistine alone, particularly in functional scores.

The dual therapy resulted in a higher percentage of patients experiencing no impairment (47% vs. 27% with monotherapy), while maintaining a low incidence of adverse events, indicating it is a safe and potentially more effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Betahistine plus piracetam dual therapy versus betahistine monotherapy for peripheral vestibular vertigo: a confounder-corrected subanalysis of the OSVaLD study. Melnikov, OA., Lilenko, SV., Nauta, J., et al.[2022]

Vertigo, a symptom of balance disturbance, can have various causes and requires careful differentiation for effective treatment.

Betahistin is highlighted as a long-term treatment option for vestibular disorders, as it not only has positive effects on blood flow but also inhibits central vestibular activity, making it a suitable choice for managing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Otogenic vertigo. Differentiation and therapy]. Stoll, W.[2007]

In a study of 65 patients with chronic vestibular dysfunction, 59% experienced dramatic improvements in their symptoms after undergoing customized vestibular habituation therapy, allowing them to resume normal activities.

The therapy serves as a valuable alternative to traditional medication, and for patients who do not respond adequately, it may indicate the need for surgical intervention, particularly in cases of unilateral peripheral lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Habituation therapy for chronic vestibular dysfunction: preliminary results. Telian, SA., Shepard, NT., Smith-Wheelock, M., et al.[2017]

In a retrospective study of 32 patients, closely monitored vestibular rehabilitation therapy significantly improved balance and gait, as measured by the Dynamic Gait Index, compared to home exercise programs.

Patients receiving closely monitored therapy had a mean improvement of 7.83 points on the Dynamic Gait Index, while those doing home exercises improved by only 2.79 points, indicating that supervised therapy may lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of close monitoring in vestibular rehabilitation therapy. Itani, M., Koaik, Y., Sabri, A.[2019]

Citations

1. withpower.com withpower.com/trial/phase-vestibular-schwannomas-7-2022-5c863

SWAN Therapy for Vestibular Disorders (SWAN Trial) This trial tests a device that helps patients practice head movements to reduce motion sickness and improve balance after certain surgeries.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38941638/

Hearing preservation outcomes using direct cranial nerve ... The result of this interactive model study proposes that there may be a higher chance of hearing preservation when using ABR+DCNEM rather ...

3. montefioreeinstein.org montefioreeinstein.org/news/2024/09/16/montefiore-einstein-comprehensive-cancer-center-establishes-new-immunotherapy-institute

Montefiore Einstein Comprehensive Cancer Center ... Programs & Services. Division of General Obstetrics & Gynecology; Division of Maternal-Fetal Medicine

4. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2021_AJA-21-00165

Vestibular Rehabilitation Effectiveness for Adults With Mild ... Results suggest VRT is an effective treatment option for patients with persistent/lingering symptoms after concussion/mTBI, as demonstrated by self-reported ...

5. mdpi.com mdpi.com/2077-0383/13/14/4183

Customized Vestibular Rehabilitation for ... The purpose of this study is to assess the impact of our rehabilitation program in adult patients who had vestibular schwannoma excision ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3259492/

Vestibular Rehabilitation Therapy: Review of Indications ... Vestibular rehabilitation therapy (VRT) is an exercise-based treatment program designed to promote vestibular adaptation and substitution.

7. e-rvs.org e-rvs.org/journal/view.php?doi=10.21790/rvs.2024.019

Clinical application of virtual reality for vestibular ... Studies have shown that side effects, such as nausea or discomfort from cybersickness, are minimal for most patients undergoing virtual reality- ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01729039

NCT01729039 No information is available for this page.

9. health.mil health.mil/Reference-Center/Clinical-Practice-Guidelines/2024/11/20/Vestibular-Clinical-Practice-Recommendations

Vestibular Clinical Practice Recommendations Several studies have evaluated scores on the DHI as outcomes measures in various pathologies including benign paroxysmal positional vertigo ( ...