Clinical trial NCT00350402: Masked Faces in Parkinson Disease: Mechanism and Treatment
Official title: Masked Faces in Parkinson Disease: A Randomized Double-blind Sham-treatment Controlled Clinical Trial of High Intensity Respiratory Muscle Strength Training (MST) for Treatment of Reduced Facial Expression in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
PD
masked faces
diminished facial expressivity
diminished facial expression
high intensity respiratory muscle strength training
MST
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-07-10
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of high intensity respiratory muscle strength training in treating blunted facial expression in people with Parkinson disease.

Detailed 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)

Primary outcomes:
measure: Change in Facial Entropy Score From Baseline [Off Dopamine Medication]
timeFrame: Baseline and 4 weeks (i.e., immediate after 4-week treatment)
measure: Change in Facial Entropy Score From Baseline [On Dopamine Medication]
timeFrame: Baseline and 4 weeks (i.e., immediate after 4-week intervention)
Secondary outcomes:
measure: Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)
timeFrame: Baseline and 4 weeks (i.e., immediate post-intervention)
Other outcomes:
measure: Change From Baseline in Maximal Inspiratory Pressure (MIP)
timeFrame: Baseline and 4 weeks (i.e., immediate after 4-week intervention)
Locations:
city: Gainesville
country: United States
facility: Cognitive Neuroscience Laboratory, L3-135, McKnight Brain Institute, University of Florida
state: Florida
Study officials:
affiliation: Professor and Area Head, Department of Clinical and Health Psychology, University of Florida
name: Dawn Bowers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor and Chair, Department of Communication Sciences and Disorders, University of Florida
name: Christine Sapienza, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor, Co-Director Movement Disorders Program, Medical Director, National Parkinson Foundation, Department of Neurology
name: Michael S. Okun, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor and Director of Clinical Trials, Movement Disorder Program, Department of Neurology, University of Florida
name: Hubert Fernandez, M.D.
role: PRINCIPAL_INVESTIGATOR
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