Clinical trial NCT02769039: Predictors of Motor Progression in Parkinson's Disease
Official title: Predictors of Progression to Freezing of Gait in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2016-05-11
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's Disease

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.


Eligibility criteria: 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

Primary outcomes:
measure: Magnitude of the center of pressure shift during gait initiation.
timeFrame: Measured at baseline (time 0).
measure: 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.
timeFrame: Change in magnitude over the course of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: