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

SpotOn Therapeutics

Status: Suspended

Conditions: Parkinson Disease

Treatments: Device: SpotOn balance glasses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03942172

SpotOn_03

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

SpotOn Balance

Experimental group

Description:

SpotOn Balance Glasses

Treatment:

Device: SpotOn balance glasses