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

A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness

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!

Study Overview

• Status: Completed
• Conditions: Chronic Dizziness
• Intervention / Treatment: Device: Placebo; Device: SpotOn's corrective elements for dizziness

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 44281
    • Dept Neurology, Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Collaborators: SpotOn Therapeutics Ltd.
• Investigators: Principal Investigator: Carlos Gordon, Prof, Meir Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 25, 2011
• First Submitted That Met QC Criteria: October 25, 2011
• First Posted (Estimate): October 26, 2011

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: SpotOn; Phobic Postural Vertigo; Visual Vertigo; Chronic Subjective Dizziness; Motion and Space Discomfort
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: SpotOn Specs 002