Predictors of Motor Progression in Parkinson's Disease

NCT02769039 | Completed DMC

• 2 other identifiers: 1508M772011R01NS088679-01A1
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Magnitude of the center of pressure shift during gait initiation.

  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.

  Measured at baseline (time 0).

• 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.

  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.

  Change in magnitude over the course of 3 years

Study Arms (2)

Parkinson's Disease participants

People with early Parkinson's disease with mild-to-moderate severity of disease.

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

Control participants

Volunteers who are age (+/- 3 years) and sex matched to the participants with Parkinson's disease

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

Interventions

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.

Control participants; Parkinson's Disease participants

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's Disease

You may qualify if:

• 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)

You may not qualify if:

• 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
• Pregnant women

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Movement; Neuroimaging

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 11, 2016
• Study Start: October 1, 2015
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

US (1)