NCT04093544UnknownNot Applicable
Expanding the Therapeutic Window of Deep Brain Stimulation in Parkinson's Disease by Means of Directional Leads: a Double-blind Cross-over Pilot Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Toronto
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number/incidence of adverse events
Study Overview
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 stimulation (DBS) patients.
The study will follow 2 phases.
Phase 1:
Visit 1 Screening/Baseline (T0):
As per current standard care for patients undergoing subthalamic deep brain stimulation (STN-DBS), participants will be screened 3-6 months before the DBS STN implant surgery (T0) according to the inclusion/exclusion criteria.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
Standard Stimulation
Active Comparator
Participants will receive stimulation using the best contact combination in ring mode.
Intervention: Deep brain stimulation (Device)
Directional Stimulation
Experimental
Participants will receive stimulation using the best segmented (steered) contacts.
Intervention: Deep brain stimulation (Device)
Outcomes
Primary Outcomes
Number/incidence of adverse events
Time Frame: Throughout the study, averaging 6 months
Number/incidence of adverse events
Secondary Outcomes
- Double support time measured with the Zeno Walkway(After 3 months of each intervention)
- Change from baseline in a measure of health related quality of life and non-motor symptoms of Parkinson's disease using the Parkinson's disease Questionnaire (PDQ-39)(After 3 months of each intervention)
- Change in the Movement Disorders sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS), a measure of various motor and non-motor symptoms used to assess the clinical course of Parkinson's longitudinally.(After 3 months of each intervention)
- Percentage of ON time without troublesome dyskinesias during waking hours(After 3 months of each intervention)
- Change in levodopa equivalent daily dose (LEDD)(After 3 months of each intervention)
- Walking speed measured with the Zeno Walkway(After 3 months of each intervention)
- Measure of resting-state local field potentials and functional connectivity of the brain using magnetoencephalography (MEG)(After 3 months of each intervention)
- Patients Global Impression of Change (PGIC)(After 3 months of each intervention)
- Change in articulation rate of speech using a Phonetics Software(After 3 months of each intervention)
- Change in dysfluency of speech using a Phonetics Software(After 3 months of each intervention)
- Change in the presence and severity of depressive symptoms using the Beck Depression Inventory (BDI)(After 3 months of each intervention)
- Step length measured with the Zeno Walkway(After 3 months of each intervention)
- Cadence measured with the Zeno Walkway(After 3 months of each intervention)
- Number of falls or near-falls(Collected after 3 months of each intervention, but assessing all intervention period, averaging 6 months)
- Change in intelligibility of speech using a Phonetics Software(After 3 months of each intervention)
Investigators
Alfonso Fasano
Professor of Neurology
University of Toronto
Study Sites (1)
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