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Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Clinical Core

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03021031
Recruitment Status : Enrolling by invitation
First Posted : January 13, 2017
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
The goal of this project is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.

Condition or disease Intervention/treatment
Parkinson Disease Other: Observational

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Clinical Core
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : July 1, 2026
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Observational
    Observational study

Outcome Measures
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Primary Outcome Measures :
  1. Registry [ Time Frame: 5 Years ]
    This is a registry of patients undergoing DBS surgery. The goal of this project is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with Parkinson's Disease
Criteria

Inclusion Criteria:

  • Age 21 years and older
  • Diagnosis of Parkinson's disease
  • Candidate for DBS

Exclusion Criteria:

  • Other significant neurological disorder
  • Diagnosis of dementia
  • Prior history of stereotactic neurosurgery for treatment of Parkinson's disease, tremor, or dystonia.
  • 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): NCT03021031


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
More Information
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Additional Information:

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03021031    
Other Study ID Numbers: NEURO-2016-25066
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Keywords provided by University of Minnesota:
Parkinson's Disease
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