Physiological Investigations of Movement Disorders
|First Received Date ICMJE||November 24, 2009|
|Last Updated Date||March 14, 2014|
|Start Date ICMJE||October 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||MRI Signals, EEG/MEG signals, Ampitude of muscle potentials (MEP) evocked by TMS.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01019343 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Physiological Investigations of Movement Disorders|
|Official Title ICMJE||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 substudies. 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 substudies 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 substudies 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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|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||1050|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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:
ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR TMS:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01019343|
|Other Study ID Numbers ICMJE||100009, 10-N-0009|
|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||January 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP