Physiological Investigations of Movement Disorders
|ClinicalTrials.gov Identifier: NCT01019343|
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : February 19, 2018
|First Submitted Date||November 24, 2009|
|First Posted Date||November 25, 2009|
|Last Update Posted Date||February 19, 2018|
|Start Date||October 20, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||MRI Signals, EEG/MEG signals, Ampitude of muscle potentials (MEP) evocked by TMS.|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01019343 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Physiological Investigations of Movement Disorders|
|Official Title||Physiological Investigations of Movement Disorders|
The purpose of this protocol is to improve understanding of the pathophysiology of movement disorders by performing small behavioral, electrophysiological and neuroimaging sub-studies. This will allow identifying dysfunction of the central nervous system that causes behavioral abnormalities seen in movement disorder patients. This will also help to determine potential diagnostic or therapeutic targets. Some sub-studies will require healthy volunteers. We will conduct:
This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, peripheral nerve stimulation, TMS).
We intend to study 600 healthy volunteers and 350 patients with diagnoses of movement disorders.
We will design small projects as ideas arise in our patient population that are pertinent to the theme of movement disorder pathophysiology. We will investigate patients with movement disorders or healthy volunteers in the resting state or while they perform simple motor or sensory tasks. If a small study leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory sub-studies performed in the present protocol.
MRI: we will analyze measures such as the amplitude of the BOLD signal (fMRI); tractography between seed and target regions of interest (using DTI); morphometry of brain regions (using VBM); and different neurotransmitter levels in brain regions of interest (using MRS).
EEG and MEG: we will quantify measures such as event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest.
TMS: we will analyze measures such as MEP amplitude and central conduction time.
Behavioral measures: we will quantify measures such as reaction times to initiate movements, EMG patterns, movement kinematics (position, velocity, acceleration, curvature).
We may measure autonomic data during the course of the experiment (such as blood pressure, skin conductance, and respiratory rate) which would correlate to the outcome measures.
|Study Design||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.
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
INCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS:
INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS:
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR fMRI:
We will follow the NMR Center guidelines for MR safety.
Some of the exclusions are:
ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR TMS:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100009
|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||February 5, 2018|