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

• ClinicalTrials.gov Identifier: NCT02132052
• Recruitment Status: Active, not recruiting
• First Posted: May 6, 2014
• Last Update Posted: January 18, 2020
• Sponsor: University of Colorado, Denver
• 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

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

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

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