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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 : Recruiting
First Posted : May 6, 2014
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Investigators hypothesize that there are specific characteristic of each cognitive and motor condition that can be defined using brains scans.

Condition or disease
Essential Tremor Multiple System Atrophy Corticobasal Degeneration Supranuclear Palsy, Progressive Parkinson Disease

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
Estimated Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Defining Cognitive and Motor Phenotypes of Parkinson's Disease (PD) With Magnetoencephalography
Actual Study Start Date : November 2013
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
University of Colorado Hospital Movement Disorders Clinic Patients
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132052


Contacts
Contact: Sarah Rogers 303 724 8655 Sarah.Rogers@ucdenver.edu
Contact: Benzi Kluger, MD 303 724 4400 benzi.kluger@ucdenver.edu

Locations
United States, Colorado
University Of Colorado. Denver, MEG Lab Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Benzi Kluger, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02132052     History of Changes
Other Study ID Numbers: 11-0952
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Keywords provided by University of Colorado, Denver:
Essential Tremor
Multiple System Atrophy
Corticobasal Degeneration
Supranuclear Palsy, Progressive
Parkinson's Disease
PD

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Parkinson Disease
Atrophy
Tremor
Essential Tremor
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Eye Diseases