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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Meir Medical Center
Sponsor:
Collaborator:
SpotOn Therapeutics LTD
Information provided by (Responsible Party):
carlos gordon, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01460121
First received: October 25, 2011
Last updated: June 22, 2014
Last verified: June 2014

October 25, 2011
June 22, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
Dizziness Handicap Inventory (DHI) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: Yes ]

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

Same as current
Complete list of historical versions of study NCT01460121 on ClinicalTrials.gov Archive Site
Vertigo Symptom Scale-Short Form [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
Vertigo Symptom Scale-Short Form Dynamic Gait Index 10 Meter Walk test. Berg Balance Scale (BBS) SF-36 Beck Depression Inventory Index Beck Anxiety Inventory index
Same as current
Not Provided
Not Provided
 
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!

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Dizziness
  • 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
  • Experimental: SpotOn's corrective elements
    Intervention: Device: SpotOn's corrective elements for dizziness
  • Placebo Comparator: Placebo corrective elements
    Interventions:
    • Device: SpotOn's corrective elements for dizziness
    • Device: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Carlos R Gordon, Prof. 972-9-7471581 cgordon@post.tau.ac.il
Israel
 
NCT01460121
SpotOn Specs 002
No
carlos gordon, Meir Medical Center
Meir Medical Center
SpotOn Therapeutics LTD
Principal Investigator: Carlos Gordon, Prof Meir Medical Center
Meir Medical Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP