Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
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Purpose
The diagnosis and management of acute vertigo and dizziness is most of the time an easy task for the general practitioner. However, following an acute vestibular disorder and very often with no any overt cause, a considerable number of patients complain on chronic dizziness and subjective disturbance of balance despite normal clinical and laboratory tests. Patients describe that perceptual visual stimulus provoke or aggravate their symptoms that are frequently accompanied by anxiety. These cases have been described in the medical literature as Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness and Motion and Space Discomfort (2,3,4,5). Treatment of these conditions includes physical therapy (similar to vestibular rehabilitation exercises) and anti-anxiety or anti-depressant agents such as benzodiazepines and SSRI, however, the effectiveness of these approaches is debatable.
Because visual stimuli play a crucial role in space orientation and motion perception, it is reasonable to hypothesize that certain visual stabilizing signals applied on the peripheral visual field (that is involved mainly in the perception of motion) could be of help in patients suffering from dizziness. This is the rationale of a new technology (SMB- Senso Mental Balance Technology) developed to alleviate the feelings of dizziness.
Trial is conducted in Meir Medical Center, Israel. Recruitment only in Israel!
| Condition | Intervention |
|---|---|
|
Chronic Dizziness |
Device: SpotOn's corrective elements for dizziness Device: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness |
- Dizziness Handicap Inventory (DHI) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: Yes ]
The change from baseline in dizziness symptoms as measured by Dizziness Handicap Inventory (DHI)
The change from baseline in balance as measured by the Activities-specific and Balance Confidence (ABC) Scale.
Safety:AE incidence Physical, neuro-otologic and neurological examination Static/dynamic/positioning examination
- Vertigo Symptom Scale-Short Form [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]Vertigo Symptom Scale-Short Form Dynamic Gait Index 10 Meter Walk test. Berg Balance Scale (BBS) SF-36 Beck Depression Inventory Index Beck Anxiety Inventory index
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SpotOn's corrective elements |
Device: SpotOn's corrective elements for dizziness
Eyeglasses with dizziness correction elements (real SpotOn eyeglasses) or eyeglasses with placebo (sham eyeglasses) elements will be worn during the whole four weeks study period.
|
| Placebo Comparator: Placebo corrective elements |
Device: SpotOn's corrective elements for dizziness
Eyeglasses with dizziness correction elements (real SpotOn eyeglasses) or eyeglasses with placebo (sham eyeglasses) elements will be worn during the whole four weeks study period.
Device: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 18≤ years ≤85
- Clinical diagnosis of chronic dizziness primary or secondary to vestibular disorder.
- Stable symptoms for more than one month and less than a year.
- Ability to perform all tests (including computerized test) and interviews.
- Gave informed consent for participation in the study.
Exclusion Criteria:
- Dizziness disease with fluctuating symptoms such as in active Meniere's disease or Benign Paroxysmal Positional Vertigo
- CNS disease or injuries
- Dizziness caused as a result of previous whiplash
- Any active or non-controlled disease that might cause dizziness (e.g. non-controlled diabetes, hypertension, anemia, respiratory, cardiovascular or endocrinological disorder etc.)
- Pregnant women
- Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.
Contacts and Locations| Contact: Carlos R Gordon, Prof. | 972-9-7471581 | cgordon@post.tau.ac.il |
| Israel | |
| Dept Neurology, Meir Medical Center | Recruiting |
| Kfar Saba, Israel, 44281 | |
| Contact: Carlos R Gordon, MD 972-9-7471581 cgordon@post.tau.ac.il | |
| Principal Investigator: Carlos R Gordon, MD | |
| Principal Investigator: | Carlos Gordon, Prof | Meir Medical Center |
More Information
No publications provided
| Responsible Party: | carlos gordon, Professor, Department of Neurology, Meir Medical Center, Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT01460121 History of Changes |
| Other Study ID Numbers: | SpotOn Specs 002 |
| Study First Received: | October 25, 2011 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Meir Medical Center:
|
Phobic Postural Vertigo Visual Vertigo Chronic Subjective Dizziness Motion and Space Discomfort SpotOn |
Additional relevant MeSH terms:
|
Dizziness Vertigo Sensation Disorders Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Vestibular Diseases Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013