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

NCT03942172 | Suspended DMC

• 1 other identifier: SpotOn_03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

SpotOn Balance

EXPERIMENTAL

SpotOn Balance Glasses

Device: SpotOn balance glasses

Interventions

SpotOn balance glasses DEVICE

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

SpotOn Balance

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SpotOn Therapeutics Ltd.: lead

Study Sites (1)

RAMBAM Health centre

Haifa, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ilana Shlezinger, MD

  Rambam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: November 27, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

IL (1)