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

NCT01981577 | Unknown

• 1 other identifier: NL42613.068.13
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Subthalamic Nucleus; Ultrahigh field Magnetic Resonance imaging; Functional connectivity; Structural connectivity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Patients with Parkinson's Disease

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Parkinson's patients scheduled for deep brain stimulation surgery at Maastricht University Medical Center * Healthy volunteers from a community sample

You may qualify if:

• Both groups:
• Mental competence
• Group 1:
• Parkinson's disease patients scheduled for deep brain stimulation surgery
• Group 2:
• Age and gender matched volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Yasin Temel, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit R Plantinga, MSc.

CONTACT

+31 43 3881033; B.R.Plantinga@tue.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: November 11, 2013
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

NL (1)