Predictors of Motor Progression in Parkinson's Disease

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

Patrocinadores

Patrocinador principal: University of Minnesota

Colaborador: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente University of Minnesota
Resumen breve

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.

Estado general Completed
Fecha de inicio October 1, 2015
Fecha de Terminación May 31, 2019
Fecha de finalización primaria May 31, 2019
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Magnitude of the center of pressure shift during gait initiation. Measured at baseline (time 0).
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 years
Inscripción 72
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: No intervention. Observational studies of sleep, movement and brain imaging

Descripción: 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.

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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

Género: All

Edad mínima: 21 Years

Edad máxima: 75 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Ubicación
Instalaciones: University of Minnesota
Ubicacion Paises

United States

Fecha de verificación

June 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Parkinson's Disease participants

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

Etiqueta: Control participants

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

Datos del paciente Undecided
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov