Status:
UNKNOWN
Flexible vs. Standard Deep Brain Stimulation Programming in Parkinson Disease Patients
Lead Sponsor:
University of Toronto
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Exploring the benefits of the linear lead in deep brain stimulation.
Detailed Description
Detailed Description: This is a single-centre, double-blinded cross-over study comparing the 4 contact vs 8 contact electrodes of deep brain stimulation (DBS) patients. The study will follow 2 phase...
Eligibility Criteria
Inclusion
- 1\) Patients with a diagnosis of PD according to the British Parkinson's Disease Society
- Brain Bank criteria (Hughes, Daniel, Kilford, \& Lees, 1992), who fulfilled the inclusion and exclusion criteria proposed by the core assessment programme for surgical interventional therapies in PD panel (Defer, Widner, Marié, Rémy, \& Levivier, 1999)
- 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 STN-DBS candidates as per current standard of care. These patients will subsequently undergo STN-DBS surgery and maintain stimulation therapy.
- Quality of life and social functioning influenced by levodopa-responsive signs
- No major comorbidities
Exclusion
- 1\) Exclusion criteria will include patients with other significant neurologic or psychiatric illnesses or cognitive deficit.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04116177
Start Date
September 1 2016
End Date
June 1 2020
Last Update
October 10 2019
Active Locations (2)
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1
Movement disorders Centre, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8