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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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ClinicalTrials.gov Identifier: NCT04011449
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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:

  1. 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,
  2. How these oscillations are altered by levodopa,
  3. 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:

  1. Levodopa-resistant motor features such as postural instability and gait (including freezing of gait),
  2. Response inhibition and impulse control.

Condition or disease Intervention/treatment Phase
Parkinson Disease Parkinson Device: Medtronic RC+S DBS system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Device Implantation
Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system
Device: Medtronic RC+S DBS system
Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system




Primary Outcome Measures :
  1. Passive and Active Rigidity Quantification [ Time Frame: 6-months ]
    Peak resistive torque integral of resistive torque over the pronation and supination Range of Motion (ROM)

  2. Ballistic Elbow Flexion to a Target: Peak Velocity [ Time Frame: 6-months ]
    Peak velocity

  3. Ballistic Elbow Flexion to a Target: Stop Reaction Time [ Time Frame: 6-months ]
    Stop reaction time

  4. Rapid Alternating Pronation-Supination Movements: RMS [ Time Frame: 6-months ]
    Root Mean Square (RMS)-Displacement RMS

  5. Rapid Alternating Pronation-Supination Movements: Freezing Episodes Duration [ Time Frame: 6-months ]
    Duration of hesitation or arrest (freezing) episodes

  6. Rapid Alternating Pronation-Supination Movements: Freezing Episodes Number [ Time Frame: 6-months ]
    Number of hesitation or arrest (freezing) episodes

  7. Gait: Step length [ Time Frame: 6-months ]
    Step length

  8. Gait: Step Time [ Time Frame: 6-months ]
    Step time

  9. Gait: Double Support Time [ Time Frame: 6-months ]
    Double support time

  10. Gait: Obstacles [ Time Frame: 6-months ]
    Percentage of obstacles successfully avoided

  11. Gait: Freezing Episodes Duration [ Time Frame: 6-months ]
    Duration of freezing episodes

  12. Gait: Freezing Episodes Number [ Time Frame: 6-months ]
    Number of freezing episodes



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04011449


Contacts
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Contact: Jerrold Vitek, MD PhD 612-625-5993 vitek004@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Jerrold Vitek, MD    612-625-5993    vitek004@umn.edu   
Sponsors and Collaborators
University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04011449    
Other Study ID Numbers: NEUR-2019-27724
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
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: Yes
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