State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
Primary Purpose
Parkinson Disease, Parkinson
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medtronic RC+S DBS system
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of idiopathic PD.
- Age 45-75 years
- Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
- Clinical plan for unilateral STN- or GPi-DBS surgery to treat their clinical motor signs within the next four months
- Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process
Exclusion Criteria:
- Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., major cardiac or pulmonary disease)
- Evidence of secondary or atypical parkinsonism
- Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
- Unable to undergo MR imaging (e.g., due to incompatible implanted pacemaker)
- Previous pallidotomy or DBS surgery
- Women who are currently pregnant
- MRI brain abnormalities that could indicate a neurological disorder other than idiopathic Lewy body Parkinson's disease.
- Subjects with severe or poorly controlled depression defined according to DSM-V criteria and a scored on a validated depression assessment scale.
- Epilepsy
- Immunocompromised
- Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
- Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device Implantation
Arm Description
Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system
Outcomes
Primary Outcome Measures
Passive and Active Rigidity Quantification
Peak resistive torque integral of resistive torque over the pronation and supination Range of Motion (ROM)
Ballistic Elbow Flexion to a Target: Peak Velocity
Peak velocity
Ballistic Elbow Flexion to a Target: Stop Reaction Time
Stop reaction time
Rapid Alternating Pronation-Supination Movements: RMS
Root Mean Square (RMS)-Displacement RMS
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Duration
Duration of hesitation or arrest (freezing) episodes
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Number
Number of hesitation or arrest (freezing) episodes
Gait: Step length
Step length
Gait: Step Time
Step time
Gait: Double Support Time
Double support time
Gait: Obstacles
Percentage of obstacles successfully avoided
Gait: Freezing Episodes Duration
Duration of freezing episodes
Gait: Freezing Episodes Number
Number of freezing episodes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04011449
Brief Title
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
Official Title
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of recruitment
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary objectives.
The ability of the RC+S to record Local Field Potentials (LFP's) is novel in Deep Brain Stimulation (DBS) technology. The primary goals of this project are to use this function of the RC+S to characterize:
The state- and target-dependency of neuronal oscillations in the subthalamic nucleus (STN), internal globus pallidus (GPi) or external globus pallidus (GPe) of patients with PD,
How these oscillations are altered by levodopa,
The effects of unilateral standard clinical isochronal (e.g. 140 Hz) GPi-, GPe-, and STN-DBS on oscillatory activity and its relationship to the presence and severity of parkinsonian motor signs.
These experiments will leverage the capacity to record LFPs from macroelectrodes implanted in either the GPi/GPe or STN using the Medtronic RC+S DBS system. The long-term goal for this project is to develop closed-loop methods for DBS that are state (resting vs. movement) and movement-phase appropriate.
Secondary objectives.
In addition to establishing the relationship between neural oscillations in the STN, GPi and GPe to clinical and quantitative measures of akinesia, bradykinesia, tremor and rigidity, this project will also examine the relationship of neural oscillations to:
Levodopa-resistant motor features such as postural instability and gait (including freezing of gait),
Response inhibition and impulse control.
Detailed Description
The Olympus Research System (RC+S) is an implantable pulse generator (IPG) designed to deliver deep brain stimulation (DBS) like a standard clinical neurostimulator, but which allows recordings of local field potential (LFP) activity from the implanted DBS lead.
LFPs are composite electrical signals generated by the brain. They are conventionally divided into frequency bands, as follows: 0-3 Hz (delta), 4-7 Hz (theta), 8-12 Hz (alpha), 13-30 Hz (beta), 31-200 Hz (gamma), and >200 Hz (high frequency). The instantaneous amplitude and power of the LFP recordings are believed to represent the degree of synchronization among neurons surrounding the electrode. A transient increase in power in a particular band, in response to a behavioral event, is called an event-related synchronization (ERS), while a transient decrease in power is called event-related desynchronization (ERD). ERD and ERS are typically calculated by averaging the power across time segments and comparing this average to a reference epoch.
Research staff at the University of Minnesota will follow FDA guidelines for software development for the RC+S.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Parkinson
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device Implantation
Arm Type
Experimental
Arm Description
Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system
Intervention Type
Device
Intervention Name(s)
Medtronic RC+S DBS system
Intervention Description
Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system
Primary Outcome Measure Information:
Title
Passive and Active Rigidity Quantification
Description
Peak resistive torque integral of resistive torque over the pronation and supination Range of Motion (ROM)
Time Frame
6-months
Title
Ballistic Elbow Flexion to a Target: Peak Velocity
Description
Peak velocity
Time Frame
6-months
Title
Ballistic Elbow Flexion to a Target: Stop Reaction Time
Description
Stop reaction time
Time Frame
6-months
Title
Rapid Alternating Pronation-Supination Movements: RMS
Description
Root Mean Square (RMS)-Displacement RMS
Time Frame
6-months
Title
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Duration
Description
Duration of hesitation or arrest (freezing) episodes
Time Frame
6-months
Title
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Number
Description
Number of hesitation or arrest (freezing) episodes
Time Frame
6-months
Title
Gait: Step length
Description
Step length
Time Frame
6-months
Title
Gait: Step Time
Description
Step time
Time Frame
6-months
Title
Gait: Double Support Time
Description
Double support time
Time Frame
6-months
Title
Gait: Obstacles
Description
Percentage of obstacles successfully avoided
Time Frame
6-months
Title
Gait: Freezing Episodes Duration
Description
Duration of freezing episodes
Time Frame
6-months
Title
Gait: Freezing Episodes Number
Description
Number of freezing episodes
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic PD.
Age 45-75 years
Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
Clinical plan for unilateral STN- or GPi-DBS surgery to treat their clinical motor signs within the next four months
Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process
Exclusion Criteria:
Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., major cardiac or pulmonary disease)
Evidence of secondary or atypical parkinsonism
Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
Unable to undergo MR imaging (e.g., due to incompatible implanted pacemaker)
Previous pallidotomy or DBS surgery
Women who are currently pregnant
MRI brain abnormalities that could indicate a neurological disorder other than idiopathic Lewy body Parkinson's disease.
Subjects with severe or poorly controlled depression defined according to DSM-V criteria and a scored on a validated depression assessment scale.
Epilepsy
Immunocompromised
Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
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