NCT04093544.
Study name | Expanding the therapeutic window of deep brain stimulation in Parkinson's disease by means of directional leads |
Methods | Randomised cross‐over trial |
Participants | Target sample size: 20 Inclusion criteria: diagnosis of PD according to the British Parkinson's Disease Society Brain Bank criteria, who fulfilled 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 deep brain stimulation (STN‐DBS) candidates as per current standard of care, aged 18 to 80 years, quality of life and social functioning influenced by levodopa‐responsive symptoms, no major comorbidities Exclusion criteria: people with other significant neurologic or psychiatric illnesses or cognitive deficit |
Interventions | 1. Stimulation using the best segmented (steered) contacts 2. Stimulation using the best contact combination in ring mode (control) |
Outcomes | 1. Rate of falls 2. Number/incidence of adverse events 3. Health‐related quality of life (PDQ39) Other outcomes not relevant to this review |
Starting date | May 15, 2018 |
Contact information | Prof Alfonso Fasano, University of Toronto, Canada Email: alfonso.fasano@uhn.ca |
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