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

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT05557864
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
144.2
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Deep Brain Stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 25, 2016
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2028

Arms and Interventions

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

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University Of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Colum MacKinnon, Principal Investigator, University of Minnesota
ClinicalTrials.gov Identifier:
NCT05557864
Other Study ID Numbers:
  • 1608M93561
First Posted:
Sep 28, 2022
Last Update Posted:
Jan 4, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Jan 4, 2023