Subthalamic Nucleus Connectivity in Parkinson's Disease With Ultra-high Field Magnetic Resonance Imaging

• Conditions: Parkinson Disease

• Registration Number: NCT01981577
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to investigate the segregation of the subthalamic nucleus into its motor and non-motor regions in patients with Parkinson's disease and healthy controls with the aid of ultra-high field magnetic resonance imaging.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-11
• Study Start: 2014-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-21
• Last Update Posted: 2016-03-22
• Primary Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Both groups:

• Mental competence

Group 1:

• Parkinson's disease patients scheduled for deep brain stimulation surgery

Group 2:

• Age and gender matched volunteers

Exclusion Criteria

Both groups:

• Head injury
• Stroke
• Other neurological diseases other than Parkinson's disease
• Metallic prostheses or pacemaker in the subject's body or other contra indications for MRI

Group 1:

• Inability to abstain from dopaminergic drug use

Group 2:

• Parkinson's disease
• Use of medication affecting the central nervous system

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Voxels of the subthalamic nucleus that are structurally or functionally connected to the motor cortex.	One measurement, consisting of 1 MRI scan of 1 hour	Two brain areas are said to be structurally connected if they are connected by fiber tracks computed from diffusion weighted MRI data.; Two brain areas are said to be functionally connected if they show statistically significantly correlated resting state functional MRI signals.

Secondary Outcome Measures

Name	Time	Method
Brain areas structurally and functionally connected to the stimulation zone of the optimal electrode of operated Parkinson's patients.	One measurement, consisting of 1 MRI scan of 1 hour	This results in a list with brain structures that are functionally and/or structurally connected to the stimulation zone.
Brain areas that show an activation pattern measured with functional magnetic resonance imaging, that is correlated to a motor task.	One measurement, consisting of 1 MRI scan of 1 hour	This results in a list of brain areas that are related to the motor task.
Strength of the structural and functional connectivity between the subthalamic nucleus and the motor cortex.	One measurement, consisting of 1 MRI scan of 1 hour	Strength of the structural connectivity is defined as: fractional anisotropy along computed fiber tracks between the subthalamic nucleus and the motor cortex.; Strength of the functional connectivity is defined as: height of the correlation between the resting state functional MRI signals in the subthalamic nucleus and the motor cortex.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands