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

Parkinson's Disease Clinical Trial

Official title:

Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease; Udall Project 2 Aims 1 & 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557864
• Other study ID #: 1608M93561
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: University of Minnesota
• Contact: Colum MacKinnon, PhD
• Email: cmackinn[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Deep Brain Stimulation
Pallidal Deep Brain Stimulation

Locations

Country	Name	City	State
United States	University Of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks