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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03942172
• Other study ID #: SpotOn_03
• Status: Suspended
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: SpotOn Therapeutics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• SpotOn balance glasses
SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses

Locations

Country	Name	City	State
Israel	RAMBAM Health centre	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
SpotOn Therapeutics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 weeks
Primary	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.	3 weeks
Primary	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.	3 weeks
Primary	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.	3 weeks
Primary	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.	3 weeks
Primary	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.	3 weeks