Electrical Vestibular Stimulation for Dizziness
(VST Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byRyan M Peters, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Neursantys Inc
Disqualifiers: Pacemaker, Cochlear implant, Neurological disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The aim of the study to is determine the safety, feasibility, efficacy, and persistence of non-invasive EVS to improve balance and gait performance in healthy individuals across the lifespan. Specifically, our objective is to measure balance and gait performance before, during and after exposure to single sessions and across repeated sequences of EVS at multiple study partner sites.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Electrical Vestibular Stimulation (EVS) for dizziness?
Research on a similar treatment, electrotactile vestibular substitution system (EVSS), showed that patients with vestibular loss experienced improved balance and reduced dizziness after using the system. Additionally, studies on electric stimulation in animals indicated faster recovery from balance issues, suggesting potential benefits for dizziness treatment.
12345Is electrical vestibular stimulation safe for humans?
Studies show that electrical vestibular stimulation (EVS) is generally safe for humans, with no reported side effects in a study involving stroke patients and a focus on long-term usage safety in another study.
678910How is the treatment Electrical Vestibular Stimulation (EVS) unique for treating dizziness?
Electrical Vestibular Stimulation (EVS) is unique because it uses electrical currents to directly stimulate the vestibular system, which is responsible for balance and spatial orientation. Unlike traditional treatments like medication or surgery, EVS aims to artificially restore vestibular function and has shown promise in improving balance and reducing dizziness by enhancing vestibular compensation.
211121314Eligibility Criteria
This trial is for healthy individuals who experience dizziness and are interested in testing a non-invasive treatment to improve balance and gait. Specific eligibility criteria details were not provided, so general health status may be considered.Inclusion Criteria
I can walk up to 200m by myself.
I can stand with my feet together and eyes open or closed for at least 1 minute.
Exclusion Criteria
I can understand and agree to the study's requirements.
I don't have any neurological or musculoskeletal issues except for the condition being studied.
Participants must not be using a pacemaker, cochlear implant, or any other implanted electronic device
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo 18 sessions of electrical vestibular stimulation (EVS) over a 5-6 week period to improve balance and gait performance.
5-6 weeks
18 visits (in-person)
Follow-up
Participants are monitored for persistence of performance improvements with follow-up sessions at 3 weeks, 6 weeks, 3 months, and 6 months post-treatment.
6 months
4 visits (in-person)
Participant Groups
The study tests the effects of Electrical Vestibular Stimulation (EVS) on balance and gait compared to a sham (fake) treatment. Participants will have their performance measured before, during, and after EVS sessions at various locations.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Electrical vestibular stimulation treatmentExperimental Treatment1 Intervention
Participants in this Arm will receive active treatment with swsEVS applied
Group II: Sham stimulation treatmentPlacebo Group1 Intervention
Participants in this Arm will receive sham treatment with no swsEVS applied.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Caring Hands CaregiversCupertino, CA
NeursantysMenlo Park, CA
University of CalgaryCalgary, Canada
Sparx Wellness InstituteDieppe, Canada
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Who Is Running the Clinical Trial?
Neursantys IncLead Sponsor
MitacsIndustry Sponsor
University of CalgaryCollaborator
References
Vestibular rehabilitation with electrotactile vestibular substitution: early effects. [2021]We aimed to determine the early efficacy of vestibular rehabilitation with electrotactile vestibular substitution system (EVSS) as a new treatment modality in patients with bilateral vestibular loss due to aminoglycoside-induced ototoxicity. Six men and four women with bilateral vestibular failure were rehabilitated with EVSS prospectively. Patients were trained with EVSS for ten sessions each lasted 20 min, two sessions per day. Sensory organization test (SOT) protocol and dizziness handicap inventory (DHI) were used to compare pre- and post-training results of the rehabilitative treatment. Post-training tests were done at the first day of post-treatment period. All ten patients in the standardized testing subset demonstrated improved scores in the composite SOT scores and in the functional transfer testing with DHI after 5 days of training with the EVSS. In conclusion, these preliminary results demonstrate efficacy of the EVSS in improving patients symptoms and signs and signify the evidence of sensory substitution in the early post-training period.
Effect of electric stimulation on vestibular compensation in guinea pigs. [2019]The effect of electric stimulation on vestibular compensation was studied in guinea pigs. Pharmacological labyrinthectomy was performed by injecting chloroform into the right middle ear under light ether anesthesia. The guinea pigs were divided into four groups: a control group which was not electrically stimulated after labyrinthectomy, a group stimulated with 0.6 mA square wave, a group stimulated with 0.3 mA square wave, and a group stimulated with 0.6 mA pulse wave. Electric stimulation, which started 1 h and 15 min after labyrinthectomy, was given through retroauricular electrodes. Nystagmus and head deviations were recorded and analyzed to assess the process of compensation at 1, 2, 3, 4, 5, 8, 12, 18 and 24 h after labyrinthectomy. Electrically stimulated groups, especially group 0.6 mA square wave and group 0.6 mA pulse wave, showed faster compensation in nystagmus and head-body deviation than the control group. Therefore, in this study, electric stimulation seemed to contribute favorably to vestibular compensation.
Effectiveness of conventional versus virtual reality-based vestibular rehabilitation exercises in elderly patients with dizziness: a randomized controlled study with 6-month follow-up. [2022]To investigate the effect of vestibular rehabilitation exercises supported with virtual reality containing real-life environments on dizziness, static and dynamic balance, functional mobility, fear of falling, anxiety, and depression in elderly patients with dizziness.
The effectiveness of exercise-based vestibular rehabilitation in adult patients with chronic dizziness: A systematic review. [2019]Background: Dizziness is a non-specific term used by patients to describe several symptoms ranging from true vertigo, light headedness, disorientation or sense of imbalance. Vestibular rehabilitation (VR) is a specific form of exercise-based therapy programme aimed at alleviating the primary and secondary problems of a vestibular pathology. The aim of this study was to investigate the effectiveness of exercise-based vestibular rehabilitation in adult patients with chronic dizziness. Methods: The following five databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE, PubMed, the Physiotherapy Evidence Database (PEDro) and Scopus (Elsevier). Two investigators independently reviewed all articles and a systematic review of literature was performed using the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). The articles were included if they met the following inclusion criteria: (1) randomised controlled trial, (2) people with chronic dizziness, (3) adults aged 18 or over, (4) exercise-based VR, (5) VR exercises compared with sham or usual care, non-treatment or placebo and (6) only studies published full text in English. Results: The initial search identified 304 articles, four of which met the criteria for analysis. All studies involved some form of vestibular rehabilitation, including vestibular compensation, vestibular adaptation and substitution exercises. These exercises were compared with usual medical care (three studies) or placebo eye exercise (one study). The Vertigo Symptom Scale was the most commonly used outcome measure to assess subjective perception of symptoms of dizziness (three studies). According to the PEDro scale, three studies were considered to be of high quality, and one was rated as fair.  Conclusions: This review suggests that exercise-based vestibular rehabilitation shows benefits for adult patients with chronic dizziness with regard to improvement in the vertigo symptom scale, fall risk, balance and emotional status.
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.
Electrical vestibular nerve stimulation (VeNS): a follow-up safety assessment of long-term usage. [2022]This retrospective, open-label study was undertaken to assess the safety of repeated, long-term electrical vestibular nerve stimulation (VeNS). The primary outcome for this study was assessment of hearing function as reported by formal audiometry testing.
Safety of repeated sessions of galvanic vestibular stimulation following stroke: a single-case study. [2019]Galvanic vestibular stimulation (GVS) involves the delivery of small electrical current to the part of the scalp that overlies the vestibular nerves. A single, brief session transiently reduces certain types of stroke impairment with no reported side-effects. It is anticipated that further reductions will occur if the duration and frequency of stimulation is increased. The aim of the present study was to assess whether this increased exposure is well-tolerated and consistent with patient well-being.
The efficacy of vestibular electrical stimulation on patients with unilateral vestibular pathologies. [2022]This study aims to investigate the efficacy of vestibular electrical stimulation (VES) in unilateral vestibular lesions including benign paroxysmal positional vertigo (BPPV).
Dizziness and the Acute Vestibular Syndrome at the Emergency Department: A Population-Based Descriptive Study. [2019]Dizziness is a common occurrence witnessed at emergency departments (EDs). This study aims to describe the epidemiology and management of dizzy patients with and without an acute vestibular syndrome (AVS) in the ED at Umeå University Hospital.
Ocular torsion responses to sinusoidal electrical vestibular stimulation. [2021]Eye movements evoked by electrical vestibular stimulation (EVS) offer potential for diagnosing vestibular dysfunction. However, ocular recording techniques are often too invasive or impractical for routine clinical use. Furthermore, the kinematic nature of the EVS signal is not fully understood in terms of movement sensations.
Electrical Vestibular Stimulation in Humans: A Narrative Review. [2020]In patients with bilateral vestibulopathy, the regular treatment options, such as medication, surgery, and/or vestibular rehabilitation, do not always suffice. Therefore, the focus in this field of vestibular research shifted to electrical vestibular stimulation (EVS) and the development of a system capable of artificially restoring the vestibular function. Key Message: Currently, three approaches are being investigated: vestibular co-stimulation with a cochlear implant (CI), EVS with a vestibular implant (VI), and galvanic vestibular stimulation (GVS). All three applications show promising results but due to conceptual differences and the experimental state, a consensus on which application is the most ideal for which type of patient is still missing.
Gentamicin vestibulotoxicity impairs human electrically evoked vestibulo-ocular reflex. [2008]Electrical vestibular stimulation is believed to directly activate the vestibular afferents to mediate an electrically evoked vestibulo-ocular reflex (eVOR). Gentamicin, an aminoglycoside antibiotic, induces vestibulotoxicity by hair cell damage and death.
Electrical stimulation of the peripheral and central vestibular system. [2023]Electrical stimulation of the peripheral and central vestibular system using noninvasive (galvanic vestibular stimulation, GVS) or invasive (intracranial electrical brain stimulation, iEBS) approaches have a long history of use in studying self-motion perception and balance control. The aim of this review is to summarize recent electrophysiological studies of the effects of GVS, and functional mapping of the central vestibular system using iEBS in awake patients.
Electrical vestibular stimulation and space motion sickness. [2019]Electrical vestibular stimulation (EVS) in dynamic balance condition was studied in order to search for a new provocative test of space motion sickness (SMS). SMS is usually attributed to a sensory conflict caused by exposure to microgravity. Vestibular information is conflicting but also unusual and insignificant. EVS is in accordance with this feature because it is not the adequate stimulus of the vestibular receptors. EVS was achieved by means of binaural electrical stimulation. Effects of EVS were potentiated by compelling the subject to maintain dynamic balance on a seesaw. The quantification of this function was performed before during and after EVS in order to investigate a possible relationship between objective consequences of EVS i.e. dynamic balance disturbances, and the discomfort experienced by the subjects. Dynamic balancing skill was statistically worsened during EVS. Moreover EVS evoked subjective symptoms of SMS in 17 out of the 30 subjects examined. During EVS in eyes open conditions, the subjects who encountered the strongest discomfort, presented the most disturbed dynamic balance, evidencing a relationship between the level of discomfort and the imbalance arising from EVS This method could thus constitute an interesting basis of SMS ground-based test.