Predictors of Motor Progression in Parkinson's Disease

Treatment resistant motor features, such as postural instability and freezing of gait are common in people with Parkinson's disease and major contributors to morbidity and mortality. This project will use sleep studies, quantitative motor assessments and magnetic resonance imaging to examine the relationship between abnormally increased muscle activity during rapid eye movement sleep and the development and progression of treatment-resistant postural instability and gait disturbances. Specifically, the investigators will test the hypothesis that anticipatory postural adjustments (weight and pressure shifts) during gait initiation are significantly reduced in people with Parkinson's disease who have abnormally elevated muscle activity during rapid eye movement (REM) sleep compared to individuals will Parkinson's disease whose REM sleep muscle activity is normal. In addition, the investigators will test the hypothesis that the level of RSWA at baseline is predictive of measures of motor decline (postural stability and gait) and alterations in the structure and function of locomotor brainstem networks. Since sleep disorders can emerge years before a diagnosis of Parkinson's disease, establishment of a link between sleep and treatment-resistant posture and gait disorders will help identify individuals at risk of developing these disabling motor features of disease.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of idiopathic Parkinson's Disease (PD).
Age 21-75 years
Able to ambulate independently without the use of an assistive device (e.g. cane)

Exclusion criteria

History of Dementia
History of musculoskeletal disorders that adversely affects walking and/or balance
Other significant neurological disorders
Implanted deep brain stimulator(s) (DBS) or other neurosurgeries to treat PD
MRI exclusion for 7 tesla scans: presence of any metallic clips or implantable medical devices
Pregnant women

Treatment and study plan

No intervention. Observational studies of sleep, movement and brain imaging

Other

Participants will be asked to visit the University for 3 baseline visits which include a screening visit & sleep study, movement tests and magnetic resonance imaging (MRI) scans. Three years later the participant will be asked to repeat the same visits.

Primary outcomes

Magnitude of the center of pressure shift during gait initiation.

Time frame: Measured at baseline (time 0).

The magnitude of the center of pressure shift during gait initiation is calculated as the displacement of the center of pressure signal from quiet standing (baseline) to the peak lateral and posterior excursion during the anticipatory postural adjustment phase of gait initiation.
Correlation between measures of REM sleep without atonia (RSWA) at baseline and change in the magnitude of the center of pressure shift during gait initiation over the course of 3 years.

Time frame: Change in magnitude over the course of 3 years

A linear correlation analysis will be conducted between measures of RSWA at baseline versus the change in shift of the center of pressure during gait initiation between baseline and year 3.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Predictors of Progression to Freezing of Gait in Parkinson's Disease

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: May 11, 2016
Registry last updated: Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed