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 |