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Completed

NCT Number: NCT01460121

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!

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Key information

Conditions

Chronic Dizziness

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept Neurology, Meir Medical Center

Kfar Saba, 44281, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

PLACEBO

Device

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Collaborators

  • SpotOn Therapeutics Ltd.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 26, 2011
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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