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Defining Phenotypes of Movement Disorders :Parkinson's Plus Disorders (PD), Essential Tremor (ET), Cortical Basal Degeneration (CBD), Multiple Systems Atrophy (MSA), Magnetoencephalography. (PHENO)

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ClinicalTrials.gov Identifier: NCT02132052
Recruitment Status : Active, not recruiting
First Posted : May 6, 2014
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date May 2, 2014
First Posted Date May 6, 2014
Last Update Posted Date January 18, 2020
Actual Study Start Date November 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2014)
Focal oscillatory activity [ Time Frame: May 2014 ]
Focal oscillatory activity: Focal band power for delta (0.5-4Hz), theta (4-8 Hz), alpha (9- 13 Hz), low beta (13-20 Hz), high beta (20-30 Hz) and gamma (30-50 Hz) activity will be derived from the autoregressive models.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 2, 2014)
  • Spectral coherence: [ Time Frame: May 2014 ]
    2) Spectral coherence: Coherence is a measure of interdependence between two time series and can be applied to MEG data to determine functional networks.4a-chen Coherence will be derived from the autoregressive models.
  • Spectral Granger analysis: [ Time Frame: May 2014 ]
    3) Spectral Granger analysis: Granger analysis is a measure of the directionality of the relationship of two time series and can be applied to sensors or sources found to have significant coherence.
  • Reactivity: [ Time Frame: May 2014 ]
    Reactivity: Reactivity refers to changes in oscillatory activity between the eye open and eye closed conditions. Prior research in AD has shown significantly reduced reactivity compared to age-matched controls.
  • Complex network analysis: [ Time Frame: May 2014 ]
    Complex network analysis: Complex network analysis, originally developed in graph theory, is an approach to the study of complex systems such as brain networks. It allows investigators to characterize brain networks with a small number of neurobiologically meaningful and easily computable measures, including transitivity, global efficiency, and betweenness. These measures will be used to reveal the hypothesized connectivity abnormalities in PD and to differentiate different cognitive phenotypes in PD.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Defining Phenotypes of Movement Disorders :Parkinson's Plus Disorders (PD), Essential Tremor (ET), Cortical Basal Degeneration (CBD), Multiple Systems Atrophy (MSA), Magnetoencephalography.
Official Title Defining Cognitive and Motor Phenotypes of Parkinson's Disease (PD) With Magnetoencephalography
Brief Summary Investigators hypothesize that there are specific characteristic of each cognitive and motor condition that can be defined using brains scans.
Detailed Description

Specific Aim 1: Determine which features of resting Magnetoencephalography (MEG) brain activity most sensitively discriminate between PD with normal cognition, PD with mild cognitive impairment (MCI), and PD dementia (PDD). Investigators predict that frontal network slowing and connectivity will discriminate between normal cognition and MCI while visuospatial network involvement will distinguish the PDD group.

Specific Aim 2: Determine which features of resting MEG brain activity most sensitively discriminate PDD from Alzheimer's Disease. Investigators predict that PDD will be distinguished from Alzheimer's (AD) on the basis of increased network connectivity, particularly in frontal and visuospatial networks.

Specific Aim 3 Investigate how resting state MEG activity correlates with task related brain activity. Investigators predict that resting state slowing will be associated with decreased task related brain activity.

Specific Aim 4: Determine which features of resting MEG brain activity most sensitively discriminate between motor subtypes of PD and also other relevant clinical populations (essential tremor and Parkinson plus syndromes). Investigators predict that frontal and parietal slowing and connectivity will discriminate PD from related conditions and that patterns of motor cortex connectivity and activity will differentiate among PD motor phenotypes.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population University of Colorado Hospital Movement Disorders Clinic Patients
Condition
  • Essential Tremor
  • Multiple System Atrophy
  • Corticobasal Degeneration
  • Supranuclear Palsy, Progressive
  • Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 2, 2014)
18
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All subjects will be age 40 or older,
  • Be on stable medications for at least 30 days
  • Montreal Cognitive Assessment (MOCA) of 26 or higher
  • Scores within 1.5 standard deviations of age-matched norms for all neuropsychological tests
  • Parkinson's Plus Disorders (PD) will be defined using United Kingdom (UK) Brain Bank Criteria.
  • PD dementia (PDD) will be defined using the Movement Disorder Task Force 2007 criteria and supported by scores less than 1.5 standard deviations of age-matched norms in at least two domains.
  • Probable Alzheimer's Disease (AD) will be defined using the National Institute on Aging-Alzheimer Association 2011 guidelines.
  • Parkinson's Plus Disorders (PD) with mild cognitive impairment (MCI) will be defined by history, MOCA of 21 or higher, at least one score less than 1.5 standard deviations of age-matched norms, and cannot meet diagnostic criteria for PDD.
  • Essential tremor and Parkinson plus syndromes (multiple systems atrophy, corticobasal degeneration, progressive supranuclear palsy) will be defined using previously published research criteria.19-22

Exclusion Criteria

  • Features suggestive of other causes of parkinsonism/Parkinson-plus syndromes;
  • Features suggestive of other causes of dementia, including moderate to severe cerebrovascular disease by history, or imaging or history of major head trauma;
  • History of deep brain stimulation, ablation surgery, or other brain surgery;
  • Evidence for depression based on the Hospital Anxiety Depression Scale (score > 11).
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02132052
Other Study ID Numbers 11-0952
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators
Principal Investigator: Benzi Kluger, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date January 2020