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Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease

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: NCT05557864
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
Colum MacKinnon, University of Minnesota

Study Description
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Brief Summary:
This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson's disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Deep Brain Stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease; Udall Project 2 Aims 1 & 2
Actual Study Start Date : August 25, 2016
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Parkinson's disease with DBS
Participants will have a diagnosis of idiopathic PD and have undergone/will undergo neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)
 Device: Deep Brain Stimulation
Pallidal Deep Brain Stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the combined elastic, viscous and inertial resistance across conditions will be assessed by integrating the resistive torque [ Time Frame: 3 weeks ]
    Average movement rate and amplitude for each tone rate-movement amplitude interval. The amount of variability in angular displacement and velocity will be calculated using the root mean square of the zero mean signal. The structure of the variability will be calculated using the sample entropy function. In addition, we will quantify the number and duration of movement festination or freezing episodes.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of idiopathic PD
  • have undergone neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)
  • Existing 7T brain imagery

Exclusion Criteria:

  • history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
  • other significant neurological disorder
  • history of dementia or cognitive impairment as found with UBACC (or MacCAT-CR)
  • post-operative complications or adverse effects
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): NCT05557864


Contacts
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Contact: Colum MacKinnon, PhD cmackinn@umn.edu

Locations
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United States, Minnesota
University Of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Colum MacKinnon, PhD       cmackinn@umn.edu   
Sponsors and Collaborators
University of Minnesota
More Information
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Responsible Party: Colum MacKinnon, Principal Investigator, University of Minnesota
ClinicalTrials.gov Identifier: NCT05557864    
Other Study ID Numbers: 1608M93561
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: January 4, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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