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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
  Purpose

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 Intervention
Chronic Dizziness
Device: SpotOn's corrective elements for dizziness
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460121

Contacts
Contact: Carlos R Gordon, Prof. 972-9-7471581 cgordon@post.tau.ac.il

Locations
Israel
Dept Neurology, Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Carlos R Gordon, MD    972-9-7471581    cgordon@post.tau.ac.il   
Principal Investigator: Carlos R Gordon, MD         
Sponsors and Collaborators
Meir Medical Center
SpotOn Therapeutics LTD
Investigators
Principal Investigator: Carlos Gordon, Prof Meir Medical Center
  More Information

No publications provided

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
Study First Received: October 25, 2011
Last Updated: June 22, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Meir Medical Center:
Phobic Postural Vertigo
Visual Vertigo
Chronic Subjective Dizziness
Motion and Space Discomfort
SpotOn

Additional relevant MeSH terms:
Dizziness
Vertigo
Ear Diseases
Labyrinth Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Vestibular Diseases

ClinicalTrials.gov processed this record on November 27, 2014