SWAN Therapy for Vestibular Disorders (SWAN Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
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.
12345What 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.
678910Is 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.
211121314Eligibility 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 generally healthy or have a unilateral vestibular schwannoma.
Exclusion Criteria
I am currently taking medication for nausea.
I have a neck condition that limits my head movement.
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.
Participant Groups
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.
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
TestBeverly Hills, CA
Naval Medical Research UnitDayton, OH
Johns Hopkins UniversityBaltimore, MD
Loading ...
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
National Aeronautics and Space Administration (NASA)Collaborator
References
Physical therapy for central vestibular dysfunction. [2007]To determine if vestibular physical therapy (PT) leads to improved functional outcomes in people with central vestibular dysfunction.
Relationship between change in balance and self-reported handicap after vestibular rehabilitation therapy. [2019]Dizziness and balance problems are two commonly reported symptoms of vestibular system disease, with subsequent alterations in lifestyle and reports of physical, functional and emotional handicap. Vestibular rehabilitation therapy (VRT) was developed to improve the functional status of patients with vestibular dysfunction. The aim of the present study was to investigate the relationship between change in balance performance and change in self-rated handicap after a four-week home exercise programme in 16 subjects with chronic vestibular disease.
Estimating the minimal clinically important difference for balance and gait outcome measures in individuals with vestibular disorders. [2022]Vestibular Rehabilitation Therapists (VRT) utilize outcome measures to quantify gait and balance abilities in individuals with vestibular disorders (IVD). The minimal clinically important difference (MCID) in gait and balance outcome measures for IVD is unknown.
Habituation therapy for chronic vestibular dysfunction: preliminary results. [2017]Chronic vestibular dysfunction is often a frustrating problem for both patient and physician. A program of customized vestibular habituation therapy is introduced and its efficacy in a group of 65 patients is evaluated. Preliminary findings suggest that 59% of patients will have a dramatic improvement, after which their vestibular symptoms no longer cause any restriction in their lifestyles. An additional 23% of patients note considerable improvement, but have persistent symptoms that continue to restrict their activities. Vestibular habituation therapy is a rational, multidisciplinary approach to the treatment of chronic vestibular dysfunction that is a significant alternative to traditional pharmacologic management. Failure of vestibular compensation after involvement in a disciplined program of habituation therapy constitutes a much stronger indication for vestibular surgery in patients with unilateral peripheral lesions.
The Effect of Supervision in Vestibular Rehabilitation in Patients with Acute or Chronic Unilateral Vestibular Dysfunction: A Systematic Review. [2023]The investigation of supervised vestibular rehabilitation treatment role for individuals with dizziness and imbalance due to peripheral, unilateral vestibular disorders.
Health services utilization of patients with vertigo in primary care: a retrospective cohort study. [2022]Vertigo and dizziness count among the most frequent symptoms in outpatient practices. Although most vestibular disorders are manageable, they are often under- and misdiagnosed in primary care. This may result in prolonged absence from work, increased resource use and, potentially, in chronification. Reliable information on health services utilization of patients with vertigo in primary care is scarce. Retrospective cohort study in patients referred to a tertiary care balance clinic. Included patients had a confirmed diagnosis of benign paroxysmal positional vertigo (BPPV), Menière's disease (MD), vestibular paroxysmia (VP), bilateral vestibulopathy (BVP), vestibular migraine (VM), or psychogenic vertigo (PSY). All previous diagnostic and therapeutic measures prior to the first visit to the clinic were recorded. 2,374 patients were included (19.7 % BPPV, 12.7 % MD, 5.8 % VP, 7.2 % BVP, 14.1 % VM, 40.6 % PSY), 61.3 % with more than two consultations. Most frequent diagnostic measures were magnetic resonance imaging (MRI, 76.2 %, 71 % in BPPV) and electrocardiography (53.5 %). Most frequent therapies were medication (61.0 %) and physical therapy (41.3 %). 37.3 % had received homoeopathic medication (39 % in BPPV), and 25.9 % were treated with betahistine (20 % in BPPV). Patients had undergone on average 3.2 (median 3.0, maximum 6) diagnostic measures, had received 1.8 (median 2.0, maximum 8) therapies and 1.8 (median 1.0, maximum 17) different drugs. Diagnostic subgroups differed significantly regarding number of diagnostic measures, therapies and drugs. The results emphasize the need for establishing systematic training to improve oto-neurological skills in primary care services not specialized on the treatment of dizzy patients.
Incidence of complementary therapy use in patients undergoing vestibular assessment. [2015]To determine the incidence of use of complementary therapies in patients with vestibular symptoms undergoing vestibular assessment.
Current and Emerging Medical Therapies for Dizziness. [2021]Medical therapies for dizziness are aimed at vertigo reduction, secondary symptom management, or the root cause of the pathologic process. Acute peripheral vertigo pharmacotherapies include antihistamines, calcium channel blockers, and benzodiazepines. Prophylactic pharmacotherapies vary between causes. For Meniere disease, betahistine and diuretics remain initial first-line oral options, whereas intratympanic steroids and intratympanic gentamicin are reserved for uncontrolled symptoms. For cerebellar dizziness and oculomotor disorders, 4-aminopyridine may provide benefit. For vestibular migraine, persistent postural perceptual dizziness and mal de débarquement, treatment options overlap and include selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants and calcium channel blockers.
[Otogenic vertigo. Differentiation and therapy]. [2007]Disturbance of equilibrium is perceived subjectively as vertigo. The origin of this unspecified symptom can be varied and must be differentiated for causal therapy. Sudden vestibular disorders were treated symptomatically using drugs that suppress different input activities. For long-term therapy other antivertigo drugs like Betahistin are appropriate. This medication produces positive vasoactive effects and inhibits central vestibular structures. Clinicians are now challenged to design the best possible treatment and exercise regimes, including medication, for patients suffering from vestibular disturbances.
Betahistine plus piracetam dual therapy versus betahistine monotherapy for peripheral vestibular vertigo: a confounder-corrected subanalysis of the OSVaLD study. [2022]This subanalysis compared the efficacy of betahistine plus piracetam dual therapy versus betahistine monotherapy using data from OSVaLD, a 3 month, open-label, observational study conducted in 2272 patients with peripheral vestibular vertigo. Of the 1898 patients included in the original efficacy population, 1076 were from countries where betahistine plus piracetam dual therapy was prescribed to >1 patient; 114 of these 1076 patients (11%) received the dual therapy and 567 (53%) were treated with betahistine monotherapy; these patients were selected for analysis.
Vestibular Physical Therapy and Fall Risk Assessment. [2021]Vestibular physical therapy (VPT) is a specialized form of evidence-based therapy designed to alleviate primary (vertigo, dizziness, imbalance, gait instability, falls) and secondary (deconditioning, cervical muscle tension, anxiety, poor quality of life, fear of falling/fear avoidance behavior) symptoms related to vestibular disorders. This article provides an overview of VPT, highlighting various exercise modalities used to treat a variety of vestibular disorders. Patient safety and fall prevention are paramount; therefore, fall risk assessment and treatment are also addressed.
The value of close monitoring in vestibular rehabilitation therapy. [2019]Vestibular rehabilitation therapy is a well-established treatment modality for patients with vestibular problems.
Advances in Vestibular Rehabilitation. [2019]Vestibular rehabilitation is an exercise-based program that has been in existence for over 70 years. A growing body of evidence supports the use of vestibular rehabilitation in patients with vestibular disorders, and evolving research has led to more efficacious interventions. Through central compensation, vestibular rehabilitation is able to improve symptoms of imbalance, falls, fear of falling, oscillopsia, dizziness, vertigo, motion sensitivity and secondary symptoms such as nausea and anxiety. Early intervention is advised for falls prevention and symptom management; however, symptomatic patients with chronic vestibular disorders may still demonstrate benefit from a course of vestibular rehabilitation. Recent advances in balance and gait training, gaze stability training, habituation training, use of virtual reality, biofeedback, and vestibular prostheses are discussed in this chapter in the context of unilateral and bilateral vestibular disorders.
Vestibular rehabilitation therapy: review of indications, mechanisms, and key exercises. [2022]Vestibular rehabilitation therapy (VRT) is an exercise-based treatment program designed to promote vestibular adaptation and substitution. The goals of VRT are 1) to enhance gaze stability, 2) to enhance postural stability, 3) to improve vertigo, and 4) to improve activities of daily living. VRT facilitates vestibular recovery mechanisms: vestibular adaptation, substitution by the other eye-movement systems, substitution by vision, somatosensory cues, other postural strategies, and habituation. The key exercises for VRT are head-eye movements with various body postures and activities, and maintaining balance with a reduced support base with various orientations of the head and trunk, while performing various upper-extremity tasks, repeating the movements provoking vertigo, and exposing patients gradually to various sensory and motor environments. VRT is indicated for any stable but poorly compensated vestibular lesion, regardless of the patient's age, the cause, and symptom duration and intensity. Vestibular suppressants, visual and somatosensory deprivation, immobilization, old age, concurrent central lesions, and long recovery from symptoms, but there is no difference in the final outcome. As long as exercises are performed several times every day, even brief periods of exercise are sufficient to facilitate vestibular recovery. Here the authors review the mechanisms and the key exercises for each of the VRT goals.