Imaging Biomarkers in Parkinson s Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01496599|
Recruitment Status : Recruiting
First Posted : December 21, 2011
Last Update Posted : September 5, 2018
|First Submitted Date||December 17, 2011|
|First Posted Date||December 21, 2011|
|Last Update Posted Date||September 5, 2018|
|Study Start Date||November 23, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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... [ Time Frame: Ongoing ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01496599 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||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... [ Time Frame: Ongoing ]|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Imaging Biomarkers in Parkinson s Disease|
|Official Title||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. We will also study 15 age-matched healthy volunteers (HVs) as controls.
Part 2 (Longitudinal study): We will continue to study 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 1 to 3 day visit. They will have a clinical assessment, and a magnetic resonance (MR) scan, and may also have a dopamine transporter single photon emission computed tomography (DAT SPECT) scan, brain ultrasound (transcranial sonography or TCS) and/or magnetoencephalography (MEG). Subjects on Parkinson medications may have 2-3 additional MR scans in the off medications condition as tolerated.
Part 2: (Longitudinal study). Subjects will be invited for follow-up every 3 years for a total of 3 additional visits. Each follow-up will involve a 1 to 3 day visit and will consist of repeat clinical evaluations and the core imaging studies, and may include additional imaging studies (TCS, SPECT, MEG, MR scans). Patients with disease duration of less than 5 years will be followed every 18 months up to the 5th year of disease.
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
For all subjects:
For PD cohort:
For EP cohort:
Exclusion criteria for all subjects:
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||120031
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 4, 2018|