Status:
UNKNOWN
Cycling Deep Brain Stimulation on Parkinson's Disease Gait
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare...
Detailed Description
Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and multi-stepped turning are common in patients with moderate and advanced Parkinson's disease. Compared to appendicular...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic Parkinson's disease
- Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment
- Hoehn \& Yahr stage between 2-4 during off-medication
- Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale
- Willingness to comply with all study procedures
Exclusion
- Active moderate/severe psychiatric condition
- Active infection or other uncontrolled moderate/grave comorbidities
- Treatment with experimental drug
- Pregnancy or breast-feeding
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04408573
Start Date
June 19 2020
End Date
December 29 2021
Last Update
June 23 2020
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil, 05403000