Skip to content

Visualising subdivisions of the Subthalamic Nucleus in Parkinson*s Disease with Ultra-High Field MRI

Visualising subdivisions of the Subthalamic Nucleus in Parkinson*s Disease with Ultra-High Field MRI - PD STN connectivity UHF

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45690
Enrollment
100
Registered
2017-08-07
Start date
2018-03-06
Completion date
Unknown
Last updated
2024-02-28

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 PD

Interventions

Parkinson's Disease
Subdivisions
Ultra-High Field MRI

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for Parkinson's patients ;1. Patients must be mentally competent (Wilsbekwaam).;2. Patients must meet all requirements of the standard Scannexus screening form (see METC appendix).;3. Patients much be aged between 18 and 80 years old.;Inclusion criteria for Healthy Volunteers ;1. Healthy controls must be mentally competent (Wilsbekwaam).;2. Healthy controls must not be suffering from any neurological or psychiatric illnesses.;3. Healthy controls must meet all requirements of the standard Scannexus screening form (see METC appendix).;4. The age and gender of healthy control subjects should not significantly differ to the age and gender of the PD patients. ;5. Subjects must be aged between 18 and 80 years old.

Exclusion criteria

Exclusion criteria: 1. Former severe head injury requiring surgery.;2. Stroke.;3. Suffering from any other non-psychiatric brain diseases. ;4. Metallic prostheses or pacemaker in the subject*s body or other contra indications for MRI. Prior to scanning, subjects will fill out a screening form (see METC appendix). This form will be sent with the information letter to all subjects. An additional form will be filled out on the day of the scan. Both are to ensure any contra indications are known to both the subject and the scanning technician.

Design outcomes

Primary

MeasureTime frame
To create individualised, subject-specific connectivity profiles of STN structure and function by combining DWI and rs-fMRI data; specifically, to identify exclusive motor components of the STN.

Secondary

MeasureTime frame
To assess the quality differences across 3T and 7T MRI To create anatomical atlases of the STN. These atlases aim to identify the extent of individual variability, both in healthy brains and in PD. These atlases will be created by combining individual manually segmented STNs from 7T structural MRI. To develop a prognostic model that can be used to determine whether PD patients are suitable candidates for DBS. The prognostic model will be based on STN anatomy (e.g. location and size), connectivity (structural and function), pre-operative UPDRS scores, resultant DBS electrode placement and clinical outcome.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)