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

March 21, 2016 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Maastricht, Netherlands
        • Recruiting
        • Maastricht University Medical Center
        • Principal Investigator:
          • Yasin Temel, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy volunteers
Patients with Parkinson's Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voxels of the subthalamic nucleus that are structurally or functionally connected to the motor cortex.
Time Frame: 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.

One measurement, consisting of 1 MRI scan of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength of the structural and functional connectivity between the subthalamic nucleus and the motor cortex.
Time Frame: 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.

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.
Time Frame: 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.
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.
Time Frame: 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.
One measurement, consisting of 1 MRI scan of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yasin Temel, MD, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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