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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses

Clinicaltrials.gov identifier NCT03942172

Recruitment Status Suspended (The study protocol needed to be modified)

First Posted May 8, 2019

Last update posted December 13, 2019

Study Description

Brief summary:

An open-label study to evaluate the effect of SpotOn balance glasses in non-demented Parkinson's patients with balance disorders.

  • Condition or Disease:Parkinson Disease
  • Intervention/Treatment: Device: SpotOn balance glasses
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses
  • Actual Study Start Date: November 2018
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: December 2019
Arms and interventions
Arm Intervention/treatment
Experimental: SpotOn Balance
SpotOn Balance Glasses
Device: SpotOn balance glasses
SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses
Outcome Measures
  • Primary Outcome Measures: 1. Unified Parkinson's disease rating scale [ Time Frame: 3 weeks ]
    A comprehensive 50 question clinical rating scale for the assessment of both motor and non-motor symptoms associated with Parkinson's. The total cumulative score will range from 0 (no disability) to 199 (total disability).
  • 2. TIMED UP AND GO (TUG) [ Time Frame: 3 weeks ]
    The TUG test is a physical performance measure in which the ability to rise up from a seated chair position, walk 3m, turn, walk back, and sit down is timed.
  • 3. Berg Balance Scale (BBS) [ Time Frame: 3 weeks ]
    The BBS is a widely used clinical test of a person's static and dynamic balance abilities. t is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.A score of 56 indicates functional balance.
  • 4. Non-Motor Symptoms Scale (NMSS) [ Time Frame: 3 weeks ]
    The non-motor symptoms questionnaire is a 30-point, patient-based questionnaire used to determine the non-motor symptoms experienced by the patient during the past month.Responses quantify symptoms according severity (using a scale of 0-3) and frequency (using a scale of 0-4). Higher scores represent more severe and more frequent symptoms.
  • 5. 39-item Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: 3 weeks ]
    This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. It is scored on a scale of 0-100, with lower scores indicating better health and high scores more severe symptoms.
  • 6. Freeze of gait (FOG) Questionnaire [ Time Frame: 3 weeks ]
    Consists of 16 items assessing freeze of gait. Total score ranges from 0 to 24, higher score corresponds to more severe FOG.
Eligibility Criteria
  • Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Female or men

2. Diagnosed with Parkinson's disease (according to Brain Bank UK criteria)

3. Non-demented

4. Age: ≥ 30 years

5. Gait disturbances

6. Patients who are able to perform questionnaires and physical tests (including
computerized tests)

7. Gave informed consent for participation in the study

Exclusion Criteria:

1. Unstable (less than 1 month) use of concomitant medications that might affect the
balance system

2. Change of PD medications during the past month

3. Any medical condition or disorder that could produce gait or balance disturbances
unless well controlled for at least 3 months

4. Blindness

5. Currently taking part in a clinical trial or within 30 days prior to screening

6. Any known condition which in the opinion of the investigator may impair gait or
balance and/or limits the successful trial completion

Contacts and Locations
Contacts
Locations

Israel
RAMBAM Health centre
Haifa

Sponsors and Collaborators

SpotOn Therapeutics Ltd.

Investigators

Principal Investigator: Ilana Shlezinger, MD Rambam Hospital

More Information
  • Responsible Party: SpotOn Therapeutics Ltd.
  • ClinicalTrials.gov Identifier: NCT03942172 History of Changes
  • Other Study ID Numbers: SpotOn_03
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: December 13, 2019
  • Last Verified: December 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Parkinson Disease