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| Name | Class |
|---|---|
| SpotOn Therapeutics Ltd. | INDUSTRY |
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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!
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpotOn's corrective elements | Experimental |
| |
| Placebo corrective elements | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpotOn's corrective elements for dizziness | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dizziness Handicap Inventory (DHI) | 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 | After 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Vertigo Symptom Scale-Short Form | Vertigo Symptom Scale-Short Form | After 4 weeks of treatment |
| Visual Vertigo Analog Scale (VVAS) | Visual Vertigo Analog Scale (VVAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Gordon, Prof | Meir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Neurology, Meir Medical Center | Kfar Saba | 44281 | Israel |
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| Placebo | Device |
|
| After 4 weeks of treatment |
| The Activities-specific Balance Confidence (ABC) Scale | The Activities-specific Balance Confidence (ABC) Scale | After 4 weeks of treatment |
| Clinical Global Impressions-Improvement (CGI-I) scale | Clinical Global Impressions-Improvement (CGI-I) scale | After 4 weeks of treatment |
| Berg Balance Scale (BBS) | Berg Balance Scale (BBS) | After 4 weeks of treatment |
| Beck Anxiety Inventory (BAI) | Beck Anxiety Inventory (BAI) | After 4 weeks of treatment |