Imaging Biomarkers in Parkinson s Disease
|First Received Date ICMJE||December 17, 2011|
|Last Updated Date||August 22, 2014|
|Start Date ICMJE||November 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Using MRI, we will measure signal intensities of iron-rich structures using T2 sequences and calculate phase shift values in these structures with susceptibility weighted sequences. We will also measure clinical symptom severity with the UPDR sc...|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01496599 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||We will measure nigral echogenicity using transcranial ultrasound, dopaminergic function using Dat SPECT, structural changes using MRI, functional connectivity analysis using fMRI and magnetoencephagraphy and brain metabolism using MR spectoscop...|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Imaging Biomarkers in Parkinson s Disease|
|Official Title ICMJE||Imaging Biomarkers in Parkinson Disease|
- Parkinson s disease (PD) causes slow movement, stiffness, and tremor. It results from the loss of a brain chemical called dopamine. PD gets worse over time, but researchers do not fully understand why the brain cells that produce dopamine stop working or die in people with PD. This study will use different ways of imaging the brain and brain chemicals to look at PD. It will compare brain imaging in people who definitely have PD to people who might have PD and to people without signs of PD. It will provide more information how the brain in people with PD changes over time.
- To understand the changes that occur in the brains of people with Parkinson s disease.
The purpose of this protocol is to evaluate possible biomarkers for diagnosis and assessment of disease progression in Parkinson disease (PD) through multi-modal neuroimaging studies. The study will have two parts:
Part 1 (Case-control study): We will study 30 patients with well-defined PD, as defined by the UK Parkinson s Society Brain Bank diagnostic criteria [1-3]. We will also study 15 age-matched healthy volunteers (HVs) as controls.
Part 2 (Longitudinal study): We will continue to study all of the subjects from Part 1 periodically over the following 9 years. We will also study 30 subjects with early parkinsonism (EP). EP subjects are defined as individuals who have experienced at least one but fewer than 3 of the cardinal symptoms of PD at the time of enrollment.
Part 1: (Case-control study). Eligible participants will come for a 2-3 day visit. They will have a clinical assessment, brain ultrasound (transcranial sonography or TCS), dopamine transporter single photon emission computed tomography (DAT SPECT) scan, a magnetic resonance (MR) scan, and magnetoencephalography (MEG). Subjects on Parkinson medications may have 2-3 additional MR scans in the off medications condition as tolerated.
Part 2: (Longitudinal study). PD and EP subjects will be asked to follow-up annually for a total of 10 visits. After a screening visit, HV subjects will be asked to follow up annually for the first 3 years, and then every 3 years for the following 6 years, for a total of 6 visits. Each follow-up will involve a 2-3 day visit and will consist of repeat clinical evaluations and imaging studies (TCS, SPECT, MEG, MR scans).
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Parkinson Disease|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||95|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
For all subjects:
For PD cohort:
For EP cohort:
Exclusion criteria for all subjects:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01496599|
|Other Study ID Numbers ICMJE||120031, 12-N-0031|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP