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. 2022 Jun 6;2022(6):CD011574. doi: 10.1002/14651858.CD011574.pub2

NCT04408573.

Study name Cycling deep brain stimulation on Parkinson's disease gait (DBS)
Methods randomised cross‐over trial
Participants Target sample size: 30
Inclusion criteria: diagnosis of idiopathic PD, currently receiving deep brain stimulation as a PD treatment, Hoehn & Yahr stage between 2‐4 during off‐medication, underlying gait disorders despite optimal medical and stimulation treatment, willingness to comply with all study procedures
Exclusion criteria: active moderate/severe psychiatric condition, active infection or other uncontrolled moderate/grave comorbidities, treatment with experimental drug, pregnancy or breast‐feeding
Interventions 1. Two weeks of regular continuous high frequency (>130Hz) stimulation, 2 weeks of cycling high frequency (>130Hz) stimulation (40 seconds on, 2 seconds off), 2 weeks of low‐frequency (80Hz) continuous stimulation and 2 weeks of cycling low frequency (80Hz) stimulation (40 seconds on, 2seconds off)
2. Control: regular continuous high‐frequency stimulation
Outcomes 1. Rate of falls
2. Health‐related quality of life (PDQ39)
Other outcomes not relevant to this review
Starting date June 19, 2020
Contact information Dr Rubens G Cury,
University of Sao Paulo General Hospital, Email: rubens_cury@usp.br
Notes