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Flexible vs. Standard Deep Brain Stimulation Programming in Parkinson Disease Patients

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ClinicalTrials.gov Identifier: NCT04116177
Recruitment Status : Active, not recruiting
First Posted : October 4, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Alfonso Fasano, University of Toronto

Brief Summary:
Exploring the benefits of the linear lead in deep brain stimulation.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Deep brain stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Flexible vs. Standard Programming in Parkinson's Disease Patients Receiving Subthalamic Implant: a Double-blind Cross-over Trial
Actual Study Start Date : September 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Active Comparator: Standard Stimulation
Standard stimulation using contact 3-6 to achieve best therapeutic stimulation
Device: Deep brain stimulation
Stimulation using VerciseTM system

Experimental: Flexible stimulation
Flexible stimulation using all available stimulation strategies provided by the VerciseTM system including stimulation of contacts 1-8 and variable pulse width and frequency.
Device: Deep brain stimulation
Stimulation using VerciseTM system




Primary Outcome Measures :
  1. Change of Overall Global functioning (PGIC) [ Time Frame: After 3 months of each intervention ]
    The PGIC evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status relative to baseline. This is a seven point scale with lower values indicating worsening and higher values, improvement.


Secondary Outcome Measures :
  1. Measure of Quality of life (PDQ-39) [ Time Frame: After 3 months of each intervention ]
    The PDQ-39 assesses individuals experiences across 8 dimensions of daily living. Each dimension is scored from 0 to 100. Lower scores mean better quality of life.

  2. Clinical change in motor symptoms using Unified Parkinson Disease Rating Scale I-IV [ Time Frame: After 3 months of each intervention ]
    The Unified Parkinson Disease Rating Scale I-IV ranges from 0-199, with higher scores meaning more severe disease

  3. Clinical change in motor symptoms [ Time Frame: After 3 months of each intervention ]
    Clinical change in motor symptoms as measured using falls diaries

  4. Number of falls [ Time Frame: After 3 months of each intervention ]
    Using a falls diary

  5. Change in the presence and severity of depressive symptoms using the Beck Depression Inventory (BDI) [ Time Frame: After 3 months of each intervention ]
    The BDI is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Scores range from 0 to 63, with higher scores meaning worse depression.

  6. Walking speed measure using Prokinetics gait analysis/Zeno Walkway [ Time Frame: After 3 months of each intervention ]
    The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Walking speed will be measured.

  7. Step length measured using Prokinetics gait analysis/Zeno Walkway [ Time Frame: After 3 months of each intervention ]
    The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Mean and coefficients of variation (standard deviation divided by the mean x 100) of step length will be measured.

  8. Cadence measured using Prokinetics gait analysis/Zeno Walkway [ Time Frame: After 3 months of each intervention ]
    The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Mean and coefficients of variation (standard deviation divided by the mean x 100) of cadence will be measured. Cadence is the number of steps per minute of walking.

  9. Double support time measured using Prokinetics gait analysis/Zeno Walkway [ Time Frame: After 3 months of each intervention ]
    The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Mean and coefficients of variation (standard deviation divided by the mean x 100) of double support time will be measured. The double support time is the the time during gait where both feet are in contact to the ground



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) Patients with a diagnosis of PD according to the British Parkinson's Disease Society

  1. 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)
  2. 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)
  3. Patients considered as STN-DBS candidates as per current standard of care. These patients will subsequently undergo STN-DBS surgery and maintain stimulation therapy.
  4. Quality of life and social functioning influenced by levodopa-responsive signs
  5. No major comorbidities

Exclusion Criteria:

1) Exclusion criteria will include patients with other significant neurologic or psychiatric illnesses or cognitive deficit.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116177


Locations
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Canada, Ontario
Movement disorders Centre, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University of Toronto
Publications:

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Responsible Party: Alfonso Fasano, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT04116177    
Other Study ID Numbers: 15-9700
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alfonso Fasano, University of Toronto:
Deep brain stimulation
Parkinson disease
Novel strategies
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases