Parkinson DiseaseNCT01981577
Subthalamic Nucleus Connectivity in Parkinson's Disease With Ultra-high Field Magnetic Resonance Imaging
An observational study of Parkinson Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Parkinson's patients scheduled for deep brain stimulation surgery at Maastricht University Medical Center * Healthy volunteers from a community sample
Who may be able to join
- Both groups:
- Mental competence
- Group 1:
- Parkinson's disease patients scheduled for deep brain stimulation surgery
- Group 2:
- Age and gender matched volunteers
Who cannot join
- 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:
Show all 10Show fewer
- Inability to abstain from dopaminergic drug use
- Group 2:
- Parkinson's disease
- Use of medication affecting the central nervous system
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht
Yasin Temel, MD, PhD
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Subthalamic Nucleus, Ultrahigh field Magnetic Resonance imaging, Functional connectivity, Structural connectivity
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's Disease | Not described | |
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voxels of the subthalamic nucleus that are structurally or functionally connected to the motor cortex.
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.
Measured: One measurement, consisting of 1 MRI scan of 1 hour
Secondary outcomes (3)
Strength of the structural and functional connectivity between the subthalamic nucleus and the motor cortex.
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.
Measured: 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.
This results in a list with brain structures that are functionally and/or structurally connected to the stimulation zone.
Measured: 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.
This results in a list of brain areas that are related to the motor task.
Measured: One measurement, consisting of 1 MRI scan of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Responsible party
- Sponsor
- Investigators
- Yasin Temel, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981577
- Sponsor's protocol ID
- NL42613.068.13
- Status last verified
- Mar 2016
- First submitted
- 30 Sep 2013
- Last updated
- 22 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-high Field Imaging of the Cortico-striato-subthalamic Functional and Structural Connectivity to Improve Deep Brain Stimulation Surgery in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT01981577
- Acronym / sponsor ID
- NL42613.068.13
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Subthalamic Nucleus, Ultrahigh field Magnetic Resonance imaging, Functional connectivity, Structural connectivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- Apr 2014
- Primary completion
- Oct 2016 (estimated)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's Disease | – | – |
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Parkinson's patients scheduled for deep brain stimulation surgery at Maastricht University Medical Center * Healthy volunteers from a community sample
Key inclusion criteria (6 listed)
- Mental competence
- Parkinson's disease patients scheduled for deep brain stimulation surgery
- Age and gender matched volunteers
Key exclusion criteria (10 listed)
- 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
- Inability to abstain from dopaminergic drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasin Temel, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgit R Plantinga, MSc. (+31 43 3881033, B.R.Plantinga@tue.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.