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

Parkinson Disease Clinical Trial

Official title:

Ultra-high Field Imaging of the Cortico-striato-subthalamic Functional and Structural Connectivity to Improve Deep Brain Stimulation Surgery in Parkinson's Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01981577
• Other study ID #: NL42613.068.13
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2013
• Last updated: March 21, 2016
• Start date: April 2014

Study information

• Verified date: March 2016
• Source: Maastricht University Medical Center
• Contact: Birgit R Plantinga, MSc.
• Phone: +31 43 3881033
• Email: B.R.Plantinga[@]tue.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voxels of the subthalamic nucleus that are structurally or functionally connected to the motor cortex.	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.	One measurement, consisting of 1 MRI scan of 1 hour	No
Secondary	Strength of the structural and functional connectivity between the subthalamic nucleus and the motor cortex.	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.	One measurement, consisting of 1 MRI scan of 1 hour	No
Secondary	Brain areas structurally and functionally connected to the stimulation zone of the optimal electrode of operated Parkinson's patients.	This results in a list with brain structures that are functionally and/or structurally connected to the stimulation zone.	One measurement, consisting of 1 MRI scan of 1 hour	No
Secondary	Brain areas that show an activation pattern measured with functional magnetic resonance imaging, that is correlated to a motor task.	This results in a list of brain areas that are related to the motor task.	One measurement, consisting of 1 MRI scan of 1 hour	No