Predictors of Motor Progression in Parkinson's Disease

NCT ID: NCT02769039

Last Updated: 2019-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson's Disease participants

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

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

Intervention Type 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

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

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1R01NS088679-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1508M77201

Identifier Type: -

Identifier Source: org_study_id

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