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

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ClinicalTrials.gov Identifier: NCT01460121
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
SpotOn Therapeutics Ltd.
Information provided by (Responsible Party):
carlos gordon, 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!


Condition or disease Intervention/treatment Phase
Chronic Dizziness Device: SpotOn's corrective elements for dizziness Device: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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
Study Start Date : February 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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: 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



Primary Outcome Measures :
  1. Dizziness Handicap Inventory (DHI) [ Time Frame: 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 :
  1. Vertigo Symptom Scale-Short Form [ Time Frame: After 4 weeks of treatment ]
    Vertigo Symptom Scale-Short Form

  2. Visual Vertigo Analog Scale (VVAS) [ Time Frame: After 4 weeks of treatment ]
    Visual Vertigo Analog Scale (VVAS)

  3. The Activities-specific Balance Confidence (ABC) Scale [ Time Frame: After 4 weeks of treatment ]
    The Activities-specific Balance Confidence (ABC) Scale

  4. Clinical Global Impressions-Improvement (CGI-I) scale [ Time Frame: After 4 weeks of treatment ]
    Clinical Global Impressions-Improvement (CGI-I) scale

  5. Berg Balance Scale (BBS) [ Time Frame: After 4 weeks of treatment ]
    Berg Balance Scale (BBS)

  6. Beck Anxiety Inventory (BAI) [ Time Frame: After 4 weeks of treatment ]
    Beck Anxiety Inventory (BAI)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460121


Locations
Israel
Dept Neurology, Meir Medical Center
Kfar Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
SpotOn Therapeutics Ltd.
Investigators
Principal Investigator: Carlos Gordon, Prof Meir Medical Center

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
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by carlos gordon, 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