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

Not Applicable

Recruiting

• Conditions: Parkinson's Disease
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT05557864
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-25
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parkinson's disease with DBS	Deep Brain Stimulation	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)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States