NCT04116177.
Study name | Flexible vs. standard deep brain stimulation programming in Parkinson disease patients |
Methods | Randomised crossover trial |
Participants | Target sample size: 10 Inclusion criteria: diagnosis of PD according to the British Parkinson's Disease Society, fulfil the inclusion and exclusion criteria proposed by the core assessment programme for surgical interventional therapies in PD panel, symptoms responsive to L‐dopa medications, but who have significant impairment related to PD that is no longer well controlled with pharmacotherapy, considered as subthalamic nucleus‐DBS candidates as per current standard of care, quality of life and social functioning influenced by levodopa‐responsive signs, no major comorbidities. Exclusion criteria: people with other significant neurologic or psychiatric illnesses or cognitive deficit |
Interventions | 1. Flexible subthalamic nucleus stimulation using all available stimulation strategies provided by the VerciseTM system including stimulation of contacts 1‐8 and variable pulse width and frequency 2. Control: standard subthalamic nucleus stimulation using contact 3‐6 to achieve best therapeutic stimulation |
Outcomes | 1. Rate of falls 2. Health‐related quality of life (PDQ39) Other outcomes not relevant to this review |
Starting date | September 2016 |
Contact information | Prof Alfonso Fasano, University of Toronto, Canada Email: alfonso.fasano@uhn.ca |
Notes |