Expanding the Therapeutic Window of Deep Brain Stimulation in Parkinson's Disease by Means of Directional Leads: a Double-blind Cross-over Pilot Study

Status: Unknown status
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Exploring directional lead

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Canada
Movement disorders Centre, Toronto Western Hospital
Recruiting
Toronto
Time Frame
Start Date: May 15, 2018
Completion Date: December 31, 2020
Participants
Target number of participants: 20
Treatments
Active Comparator: Standard Stimulation
Participants will receive stimulation using the best contact combination in ring mode.
Experimental: Directional Stimulation
Participants will receive stimulation using the best segmented (steered) contacts.
Sponsors
Leads: University of Toronto

This content was sourced from clinicaltrials.gov

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