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Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03079037
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
This study will test the hypothesis that deep brain stimulation (DBS) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal DBS thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal closed-loop biomarker varies across subcortical targets, is task dependent, or serves to re-establish a default network that removes an underlying disruptive physiological state leading to greater improvement in motor signs and task performance.

Condition or disease Intervention/treatment
Parkinson Disease Device: Stimulation

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Stimulation
Traditional deep brain stimulation
 Device: Stimulation
Traditional deep brain stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Measure local field potential (LFP) changes in subthalamic nucleus (STN) and globus pallidus (GP) in OFF and ON states of stimulation and medication [ Time Frame: 2 days ]
    Clinical ratings scales (MDS-UPDRS)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's Disease (PD)
Criteria

Inclusion Criteria:

  • Diagnosis of idiopathic PD
  • A history of a good response to levodopa (carbidopa/levodopa) defined as at least a 30% improvement in motor UPDRS score
  • DBS surgery or IPG battery replacement at UMN is planned as part of routine clinical care.

Exclusion Criteria:

  • Other significant neurological disorder
  • History of dementia
  • Prior history of stereotactic neurosurgery
  • Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
  • Pregnant women
Contacts and Locations
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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): NCT03079037


Contacts
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Contact: Michael C. Park, MD/PhD 6126264706 mcpark@umn.edu
Contact: Kelly Ryberg, MA 6126263439 rybe0010@umn.edu

Locations
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United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Michael C. Park, MD/PhD    612-626-4706    mcpark@umn.edu   
Contact: Kelly Ryberg, MA    6126263439    rybe0010@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Michael C. Park, MD/PhD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03079037    
Other Study ID Numbers: NEUR-2016-22287
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Synucleinopathies
Neurodegenerative Diseases