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Predictors of Motor Progression in Parkinson's Disease

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Parkinson's Disease

Treatments

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

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT02769039
1R01NS088679-01A1 (U.S. NIH Grant/Contract)
1508M77201

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

72 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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