Parkinson Disease
Conditions
Brief summary
An open-label study to evaluate the effect of SpotOn balance glasses in non-demented Parkinson's patients with balance disorders.
Interventions
DEVICESpotOn balance glasses
SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses
Sponsors
SpotOn Therapeutics Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Israel
Outcome results
None listed