SWAN Therapy for Vestibular Disorders

(SWAN Trial)

Recruiting at2 trial locations

Overseen by Matthew Stewart, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Anti-nausea, Motion sickness

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that SWAN Therapy for Vestibular Disorders is an effective treatment?

The available research shows that vestibular rehabilitation therapy, which is similar to SWAN Therapy, can improve balance and reduce feelings of dizziness in people with vestibular disorders. One study found that after a four-week exercise program, participants reported better balance and felt less handicapped by their symptoms. Another study on a similar therapy called habituation therapy showed that 59% of patients experienced significant improvement, with their symptoms no longer affecting their daily lives. This suggests that SWAN Therapy could be effective in helping people with vestibular disorders manage their symptoms and improve their quality of life. ^{1 2 3 4 5}

What safety data exists for SWAN Therapy for vestibular disorders?

The provided research does not specifically mention SWAN Therapy or its safety data. It discusses various treatments for vestibular disorders, including medications like betahistine, diuretics, and complementary therapies, but does not provide specific safety data for SWAN Therapy or its alternative names. ^{6 7 8 9 10}

Is SWAN, Traditional Therapy a promising treatment for vestibular disorders?

Yes, Traditional Therapy, also known as Vestibular Rehabilitation Therapy, is a promising treatment for vestibular disorders. It helps improve balance, reduce dizziness, and enhance daily activities by using exercises that train the body to adapt and compensate for balance issues. This therapy has been supported by research and has been used successfully for many years to help people with vestibular problems. ^{2 11 12 13 14}

Research Team

Matthew Stewart, MD PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• SWAN (Procedure)
• Traditional Therapy (Behavioral Intervention)

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.

Participant Groups

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 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+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

National Aeronautics and Space Administration (NASA)

Collaborator

Trials

32

Recruited

1,900+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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 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]

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]

References

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

Physical therapy for central vestibular dysfunction. [2007]

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

Relationship between change in balance and self-reported handicap after vestibular rehabilitation therapy. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Estimating the minimal clinically important difference for balance and gait outcome measures in individuals with vestibular disorders. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Habituation therapy for chronic vestibular dysfunction: preliminary results. [2017]

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

The Effect of Supervision in Vestibular Rehabilitation in Patients with Acute or Chronic Unilateral Vestibular Dysfunction: A Systematic Review. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Health services utilization of patients with vertigo in primary care: a retrospective cohort study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Incidence of complementary therapy use in patients undergoing vestibular assessment. [2015]

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

Current and Emerging Medical Therapies for Dizziness. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Otogenic vertigo. Differentiation and therapy]. [2007]

10. England 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. [2022]

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

Vestibular Physical Therapy and Fall Risk Assessment. [2021]

12. England pubmed.ncbi.nlm.nih.gov

The value of close monitoring in vestibular rehabilitation therapy. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in Vestibular Rehabilitation. [2019]

14. Korea (South) pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy: review of indications, mechanisms, and key exercises. [2022]