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Recruiting NCT05557864

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

No phase Interventional Parkinson's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation.
Who it may be relevant to
Registry conditions: Parkinson's Disease. Basic parameters: 21 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Deep Brain Stimulation
    Pallidal Deep Brain Stimulation

Primary outcome measures

  • Changes in the combined elastic, viscous and inertial resistance across conditions will be assessed by integrating the resistive torque [Time frame: 3 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University Of Minnesota — Minneapolis

Identifiers

NCT: NCT05557864 · NEUR-2016-25128

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗