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Predictors of Motor Progression in Parkinson's Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02769039
Enrollment
72
Registered
2016-05-11
Start date
2015-10-01
Completion date
2019-05-31
Last updated
2019-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

OTHERNo 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.

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 yearsA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026