Ultra-high field imaging of the cortico-striato-subthalamic functional and structural connectivity to improve deep brain stimulation surgery in Parkinson's disease patients

Ultra-high field imaging of the cortico-striato-subthalamic functional and structural connectivity to improve deep brain stimulation surgery in Parkinson's disease patients - STN connectivity in PD with MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41696

Enrollment

Registered

2013-09-02

Start date

2014-04-10

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Parkinson's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For all groups: 1. Subjects must be mentally competent;For group 1 (PD patients scheduled for DBS surgery): 1. Patients suffering from Parkinson's disease who are eligible for deep brain stimulation surgery.;For group 2 (PD patients not scheduled for DBS surgery): 1. Diagnosis of idiopathic PD according to the UK Brain Bank Criteria 2. Excellent levodopa response 3. Disease course of > 3 years;For the healthy controls only: 1. Healthy volunteers with the same age and gender distribution as both patient populations.

Exclusion criteria

Exclusion criteria: For all groups: 1. Metallic prostheses or pacemaker in the subject's body or other contra indications for MRI. 2. Any neurological disease (other than PD).;For group 1 (PD patients scheduled for DBS surgery): 1. Any neurological or psychiatric disease other than PD.;For group 2 (PD patients not scheduled for DBS surgery) 1. Any neurological or psychiatric disease other than PD.;For healthy volunteers: 1. Any neurological or psychiatric disease. 2. The use of medication affecting the central nervous system.

Design outcomes

Primary

Measure	Time frame
The main study endpoint will be the structural and functional partition of the STN into its motor and non-motor regions in PD patients and healthy controls.	—

Secondary

Measure	Time frame
The secondary study parameters are: 1. The strength of the functional and structural connectivity between the STN and the motor and non-motor cortical areas in PD patients and controls. 2. The brain areas that show a significantly stronger or weaker functional or structural connectivity from the STN to the motor or limbic cortical areas or vice versa in PD patients than in controls. 3. The brain areas structurally and functionally connected to the stimulation zone of the optimal electrode (only in patients). 4. Brain areas that show an activation related to the fMRI task. 5. The brain areas that show significantly more or significantly less activation during the task fMRI in PD patients than in healthy subjects. 6. The deviation between the computed STN motor area (with 7T MRI) and the surgically determined optimal electrode location. 7. The deviation between the pre-surgically determined target location with 3T MRI (current clinical practice) and the surgically determined optimal electrode location.	—

Measure

Time frame

The secondary study parameters are: 1. The strength of the functional and structural connectivity between the STN and the motor and non-motor cortical areas in PD patients and controls. 2. The brain areas that show a significantly stronger or weaker functional or structural connectivity from the STN to the motor or limbic cortical areas or vice versa in PD patients than in controls. 3. The brain areas structurally and functionally connected to the stimulation zone of the optimal electrode (only in patients). 4. Brain areas that show an activation related to the fMRI task. 5. The brain areas that show significantly more or significantly less activation during the task fMRI in PD patients than in healthy subjects. 6. The deviation between the computed STN motor area (with 7T MRI) and the surgically determined optimal electrode location. 7. The deviation between the pre-surgically determined target location with 3T MRI (current clinical practice) and the surgically determined optimal electrode location.

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Countries

Netherlands

Outcome results