- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01981577
Subthalamic Nucleus Connectivity in Parkinson's Disease With Ultra-high Field Magnetic Resonance Imaging
Ultra-high Field Imaging of the Cortico-striato-subthalamic Functional and Structural Connectivity to Improve Deep Brain Stimulation Surgery in Parkinson's Disease Patients
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Birgit R Plantinga, MSc.
- Phone Number: +31 43 3881033
- Email: B.R.Plantinga@tue.nl
Study Locations
-
-
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Maastricht, Netherlands
- Recruiting
- Maastricht University Medical Center
-
Principal Investigator:
- Yasin Temel, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
Collaborators
Investigators
- Principal Investigator: Yasin Temel, MD, PhD, Maastricht University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL42613.068.13
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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