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

NCT ID: NCT03942172

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-27

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SpotOn Balance

SpotOn Balance Glasses

Group Type EXPERIMENTAL

SpotOn balance glasses

Intervention Type DEVICE

SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses

Interventions

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SpotOn balance glasses

SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SpotOn Therapeutics Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilana Shlezinger, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Hospital

Locations

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RAMBAM Health centre

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SpotOn_03

Identifier Type: -

Identifier Source: org_study_id