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Trial record 4 of 33 for:    Parkinson's disease | Recruiting Studies | NIH

Predictors of Motor Progression in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02769039
Recruitment Status : Recruiting
First Posted : May 11, 2016
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment
Parkinson's Disease Other: No intervention. Observational studies of sleep, movement and brain imaging

Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Progression to Freezing of Gait in Parkinson's Disease
Study Start Date : October 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

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U.S. FDA Resources

Group/Cohort Intervention/treatment
Parkinson's Disease participants
People with early Parkinson's disease with mild-to-moderate severity of disease.
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.
Control participants
Volunteers who are age (+/- 3 years) and sex matched to the participants with Parkinson's disease
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.



Primary Outcome Measures :
  1. Magnitude of the center of pressure shift during gait initiation. [ Time Frame: 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.

  2. 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. [ Time Frame: Change in magnitude 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.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's Disease
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769039


Contacts
Contact: Joshua A De Kam, BA 612-626-8052 jadekam@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Colum MacKinnon, PhD    612-625-8938    cmackinn@umn.edu   
Principal Investigator: Colum MacKinnon, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Neurological Disorders and Stroke (NINDS)

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02769039     History of Changes
Other Study ID Numbers: 1508M77201
1R01NS088679-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases