Predictors of Motor Progression in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769039
• Other study ID #: 1508M77201
• Secondary ID: 1R01NS088679-01A
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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)

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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