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

Primary Purpose

Parkinson Disease

Status
Suspended
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SpotOn balance glasses
Sponsored by
SpotOn Therapeutics Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RAMBAM Health centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SpotOn Balance

Arm Description

SpotOn Balance Glasses

Outcomes

Primary Outcome Measures

Unified Parkinson's disease rating scale
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).
TIMED UP AND GO (TUG)
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.
Berg Balance Scale (BBS)
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.
Non-Motor Symptoms Scale (NMSS)
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.
39-item Parkinson's Disease Questionnaire (PDQ-39)
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.
Freeze of gait (FOG) Questionnaire
Consists of 16 items assessing freeze of gait. Total score ranges from 0 to 24, higher score corresponds to more severe FOG.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2019
Last Updated
December 11, 2019
Sponsor
SpotOn Therapeutics Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03942172
Brief Title
Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses
Official Title
Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Suspended
Why Stopped
The study protocol needed to be modified
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SpotOn Therapeutics Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SpotOn Balance
Arm Type
Experimental
Arm Description
SpotOn Balance Glasses
Intervention Type
Device
Intervention Name(s)
SpotOn balance glasses
Intervention Description
SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses
Primary Outcome Measure Information:
Title
Unified Parkinson's disease rating scale
Description
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).
Time Frame
3 weeks
Title
TIMED UP AND GO (TUG)
Description
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.
Time Frame
3 weeks
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
3 weeks
Title
Non-Motor Symptoms Scale (NMSS)
Description
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.
Time Frame
3 weeks
Title
39-item Parkinson's Disease Questionnaire (PDQ-39)
Description
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.
Time Frame
3 weeks
Title
Freeze of gait (FOG) Questionnaire
Description
Consists of 16 items assessing freeze of gait. Total score ranges from 0 to 24, higher score corresponds to more severe FOG.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female or men Diagnosed with Parkinson's disease (according to Brain Bank UK criteria) Non-demented Age: ≥ 30 years Gait disturbances Patients who are able to perform questionnaires and physical tests (including computerized tests) Gave informed consent for participation in the study Exclusion Criteria: Unstable (less than 1 month) use of concomitant medications that might affect the balance system Change of PD medications during the past month Any medical condition or disorder that could produce gait or balance disturbances unless well controlled for at least 3 months Blindness Currently taking part in a clinical trial or within 30 days prior to screening Any known condition which in the opinion of the investigator may impair gait or balance and/or limits the successful trial completion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Shlezinger, MD
Organizational Affiliation
Rambam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAMBAM Health centre
City
Haifa
Country
Israel

12. IPD Sharing Statement

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

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