Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness

Not Applicable

Completed

• Conditions: Chronic Dizziness
• Interventions: Device: SpotOn's corrective elements for dizziness; Device: Placebo

• Registration Number: NCT01460121
• Lead Sponsor: Meir Medical Center

Brief Summary

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!

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-26
• Study Start: 2012-02
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo corrective elements	SpotOn's corrective elements for dizziness	-
SpotOn's corrective elements	SpotOn's corrective elements for dizziness	-
Placebo corrective elements	Placebo	-

Primary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory (DHI)	After 4 weeks of treatment	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

Secondary Outcome Measures

Name	Time	Method
Vertigo Symptom Scale-Short Form	After 4 weeks of treatment	Vertigo Symptom Scale-Short Form
Visual Vertigo Analog Scale (VVAS)	After 4 weeks of treatment	Visual Vertigo Analog Scale (VVAS)
The Activities-specific Balance Confidence (ABC) Scale	After 4 weeks of treatment	The Activities-specific Balance Confidence (ABC) Scale
Clinical Global Impressions-Improvement (CGI-I) scale	After 4 weeks of treatment	Clinical Global Impressions-Improvement (CGI-I) scale
Berg Balance Scale (BBS)	After 4 weeks of treatment	Berg Balance Scale (BBS)
Beck Anxiety Inventory (BAI)	After 4 weeks of treatment	Beck Anxiety Inventory (BAI)

Trial Locations

Locations (1)

Dept Neurology, Meir Medical Center; 🇮🇱 Kfar Saba, Israel