Predictors of Motor Progression in Parkinson's Disease

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: No intervention. Observational studies of sleep, movement and brain imaging

• Registration Number: NCT02769039
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control participants	No intervention. Observational studies of sleep, movement and brain imaging	Volunteers who are age (+/- 3 years) and sex matched to the participants with Parkinson's disease
Parkinson's Disease participants	No intervention. Observational studies of sleep, movement and brain imaging	People with early Parkinson's disease with mild-to-moderate severity of disease.

Primary Outcome Measures

Name	Time	Method
Magnitude of the center of pressure shift during gait initiation.	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.	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States