Parkinson DiseaseNCT03942172
Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses
A study testing SpotOn balance glasses in people with Parkinson Disease, run by SpotOn Therapeutics Ltd. at 1 site in Israel.
Trial summary
An open-label study to evaluate the effect of SpotOn balance glasses in non-demented Parkinson's patients with balance disorders. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- SpotOn balance glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Nov 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
An open-label study to evaluate the effect of SpotOn balance glasses in non-demented Parkinson's patients with balance disorders.
- Conditions
- Parkinson Disease
- Being tested
- SpotOn balance glasses
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpotOn balance glassesDevice
SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses
| Study group | Role | What they receive |
|---|---|---|
| SpotOn Balance | Experimental | SpotOn Balance Glasses Receives: Device: SpotOn balance glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start27 Nov 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: The study protocol needed to be modified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpotOn Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilana Shlezinger, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942172
- Sponsor's protocol ID
- SpotOn_03
- Status last verified
- Dec 2019
- First submitted
- 6 May 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses
- ClinicalTrials.gov ID
- NCT03942172
- Acronym / sponsor ID
- SpotOn_03
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study protocol needed to be modified
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SpotOn Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label study to evaluate the effect of SpotOn balance glasses in non-demented Parkinson's patients with balance disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpotOn Balance | Experimental | Device: SpotOn balance glassesSpotOn Balance Glasses |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female or men
- Diagnosed with Parkinson's disease (according to Brain Bank UK criteria)
- Non-demented
- Age: ≥ 30 years
- Gait disturbances
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpotOn balance glassesSpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses | Device | SpotOn Balance |
Primary outcome
Unified Parkinson's disease rating scale
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 3 weeks
Consists of 16 items assessing freeze of gait. Total score ranges from 0 to 24, higher score corresponds to more severe FOG.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilana Shlezinger, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpotOn balance glasses in people with Parkinson Disease, run by SpotOn Therapeutics Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's disease rating scale (time frame: 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.