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

Primary Purpose

Parkinson's Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parkinson's disease with DBS

Arm Description

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)

Outcomes

Primary Outcome Measures

Changes in the combined elastic, viscous and inertial resistance across conditions will be assessed by integrating the resistive torque
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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2022
Last Updated
October 5, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05557864
Brief Title
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease
Official Title
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease; Udall Project 2 Aims 1 & 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2016 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's disease with DBS
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Pallidal Deep Brain Stimulation
Primary Outcome Measure Information:
Title
Changes in the combined elastic, viscous and inertial resistance across conditions will be assessed by integrating the resistive torque
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colum MacKinnon, PhD
Email
cmackinn@umn.edu
Facility Information:
Facility Name
University Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colum MacKinnon, PhD
Email
cmackinn@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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