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

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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
Sponsor:
Information provided by (Responsible Party):
SpotOn Therapeutics Ltd.

Study Description
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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 Intervention/treatment Phase
Parkinson Disease Device: SpotOn balance glasses Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 27, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942172


Locations
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Israel
RAMBAM Health centre
Haifa, Israel
Sponsors and Collaborators
SpotOn Therapeutics Ltd.
Investigators
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Principal Investigator: Ilana Shlezinger, MD Rambam Hospital
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
 Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors