Status:
UNKNOWN
Expanding the Therapeutic Window of Deep Brain Stimulation in Parkinson's Disease by Means of Directional Leads
Lead Sponsor:
University of Toronto
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Exploring directional lead
Detailed Description
This is a single-centre, double-blinded cross-over study comparing the standard electrode configuration (ring-mode) vs. directional electrode configuration for steered stimulation of deep brain stimul...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of Parkinson's disease (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
- Male and female patients with idiopathic PD, who have symptoms responsive to L- dopa medications, but who have significant impairment related to PD that is no longer well controlled with pharmacotherapy (i.e., refractory to optimized medical therapy)
- Patients considered as subthalamic nucleus deep brain stimulation (STN-DBS) candidates as per current standard of care. These patients will subsequently undergo STN-DBS surgery and maintain stimulation therapy.
- Patients aged 18 to 80 years.
- Quality of life and social functioning influenced by levodopa-responsive symptoms 6) No major comorbidities
- Exclusion criteria will include patients with other significant neurologic or psychiatric illnesses or cognitive deficit.
Exclusion
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04093544
Start Date
May 15 2018
End Date
December 31 2020
Last Update
September 18 2019
Active Locations (1)
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1
Movement disorders Centre, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8