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

Not Applicable

Suspended

• Conditions: Parkinson Disease
• Interventions: Device: SpotOn balance glasses

• Registration Number: NCT03942172
• Lead Sponsor: SpotOn Therapeutics Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-27
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Status Verified: 2019-12
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SpotOn Balance	SpotOn balance glasses	SpotOn Balance Glasses

Primary Outcome Measures

Name	Time	Method
Freeze of gait (FOG) Questionnaire	3 weeks	Consists of 16 items assessing freeze of gait. Total score ranges from 0 to 24, higher score corresponds to more severe FOG.
39-item Parkinson's Disease Questionnaire (PDQ-39)	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.
TIMED UP AND GO (TUG)	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.
Unified Parkinson's disease rating scale	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).
Berg Balance Scale (BBS)	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.
Non-Motor Symptoms Scale (NMSS)	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.

Trial Locations

Locations (1)

RAMBAM Health centre; 🇮🇱 Haifa, Israel