Clinical trial NCT01460121: Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Dizziness
Keywords: Phobic Postural Vertigo
Visual Vertigo
Chronic Subjective Dizziness
Motion and Space Discomfort
SpotOn
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: SpotOn Therapeutics Ltd.
First posted: 2011-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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!


Eligibility 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.

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: After 4 weeks of treatment
Secondary outcomes:
measure: Vertigo Symptom Scale-Short Form
timeFrame: After 4 weeks of treatment
measure: Visual Vertigo Analog Scale (VVAS)
timeFrame: After 4 weeks of treatment
measure: The Activities-specific Balance Confidence (ABC) Scale
timeFrame: After 4 weeks of treatment
measure: Clinical Global Impressions-Improvement (CGI-I) scale
timeFrame: After 4 weeks of treatment
measure: Berg Balance Scale (BBS)
timeFrame: After 4 weeks of treatment
measure: Beck Anxiety Inventory (BAI)
timeFrame: After 4 weeks of treatment
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Dept Neurology, Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Carlos Gordon, Prof
role: PRINCIPAL_INVESTIGATOR
References: