The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

Facial expressions are complex signals that last only a few minutes and are important for communicating intention, motivation, and emotional states. In humans, a variety of neurological and psychiatric conditions alter the tendency to use facial signals. One of the main symptoms of Parkinson disease (PD) is diminished facial expressivity or "masked facies," which refers to the expressionless appearance of individuals with the disorder. Unfortunately, little progress has been made over the years regarding the basis of "masked faces" or strategies that might improve facial expressivity among individuals with PD. This is unfortunate because the particular symptom can have significant medical and social consequences ranging from misdiagnosis of depression to the misattribution of negative emotional states and motivation by family members and healthcare providers. The goal of this trial is to study the effectiveness of a novel, behavioral treatment approach—high intensity respiratory muscle strength training (MST)—for blunting of facial expressions in people with PD. The MST device, a mouthpiece that the participant uses to inspire against resistance, may improve the strength and mobility of muscles around the mouth that are involved in forming facial expressions. Study participation includes screening, baseline evaluations, 4 weeks of behavioral intervention, immediate post-treatment followup, and a 3-month follow-up. Participants will be randomly assigned to take part in high intensity respiratory MST, or a Sham MST. Participation in the study will last for approximately 5 months.

Eligibility Criteria:

Inclusion Criteria: - A clinical diagnosis of idiopathic Parkinson disease - Hoeh-Yahr Stage 1-3 when off medication - Stable and optimal medical regimen for at least 3 months - No previous surgical interventions for Parkinson's disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation) - Participants will include men and women between the ages of 45 and 80 years Exclusion Criteria: - Evidence of dementia based on neurocognitive testing - Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, substance abuse). Participants who are taking anti-depressants will not be excluded as long as they are not currently depressed (Beck Depression, SCID) - Other neurologic disturbance (e.g., tumor, stroke, traumatic brain injury, epilepsy) or severe chronic medical illness (e.g., HIV, metastatic cancer) - Presence of oro-facial dyskinesias - Previous surgeries to the larynx that result in poor vocal fold closure and/or positive history of head and neck cancer - History of smoking in the past 5 years - Untreated hypertension - Failing a baseline test of pulmonary function during baseline respiratory evaluation - Known respiratory complications such as chronic obstructive pulmonary disease (POCD), asthma - Previous surgical interventions for Parkinson's disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation)

Study Design:

Study Location:

Florida