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

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
Notes