NCT01981577UnknownNot Applicable
Ultra-high Field Imaging of the Cortico-striato-subthalamic Functional and Structural Connectivity to Improve Deep Brain Stimulation Surgery in Parkinson's Disease Patients
Maastricht University Medical Center1 site in 1 country20 target enrollmentStarted: April 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Voxels of the subthalamic nucleus that are structurally or functionally connected to the motor cortex.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Both groups:
- •Mental competence
- •Parkinson's disease patients scheduled for deep brain stimulation surgery
- •Age and gender matched volunteers
Exclusion Criteria
- •Both groups:
- •Head injury
- •Other neurological diseases other than Parkinson's disease
- •Metallic prostheses or pacemaker in the subject's body or other contra indications for MRI
- •Inability to abstain from dopaminergic drug use
- •Parkinson's disease
- •Use of medication affecting the central nervous system
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- 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)
Investigators
Study Sites (1)
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