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

Parkinson Disease Clinical Trial

— PHENO  

Official title:

Defining Cognitive and Motor Phenotypes of Parkinson's Disease (PD) With Magnetoencephalography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132052
• Other study ID #: 11-0952
• Status: Completed
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrophy
• Corticobasal Degeneration
• Essential Tremor
• Multiple System Atrophy
• Parkinson Disease
• Shy-Drager Syndrome
• Supranuclear Palsy, Progressive
• Tremor

Locations

Country	Name	City	State
United States	University Of Colorado. Denver, MEG Lab	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Focal oscillatory activity	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.	May 2014
Secondary	Spectral coherence:	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.	May 2014
Secondary	Spectral Granger analysis:	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.	May 2014
Secondary	Reactivity:	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.	May 2014
Secondary	Complex network analysis:	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.	May 2014