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

NCT01460121 | Completed

• 1 other identifier: SpotOn Specs 002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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!

Conditions

Chronic Dizziness

Keywords

Phobic Postural Vertigo; Visual Vertigo; Chronic Subjective Dizziness; Motion and Space Discomfort; SpotOn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Vertigo Symptom Scale-Short Form

  After 4 weeks of treatment

• Visual Vertigo Analog Scale (VVAS)

  After 4 weeks of treatment

• The Activities-specific Balance Confidence (ABC) Scale

  After 4 weeks of treatment

• Clinical Global Impressions-Improvement (CGI-I) scale

  After 4 weeks of treatment

• Berg Balance Scale (BBS)

  After 4 weeks of treatment

Study Arms (2)

SpotOn's corrective elements

EXPERIMENTAL

Device: SpotOn's corrective elements for dizziness

Placebo corrective elements

PLACEBO COMPARATOR

Device: SpotOn's corrective elements for dizziness; Device: Placebo

Interventions

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 corrective elements; SpotOn's corrective elements

Placebo DEVICE

Placebo corrective elements

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead
• SpotOn Therapeutics Ltd.: collaborator

Study Sites (1)

Dept Neurology, Meir Medical Center

Kfar Saba, 44281, Israel

Location

Study Officials

• Carlos Gordon, Prof

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neurology, Meir Medical Center

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 26, 2011
• Study Start: February 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

IL (1)