Masked Faces in Parkinson Disease: Mechanism and Treatment

Phase 2

Completed

Conditions: Parkinson's Disease

Registration Number: NCT00350402

Lead Sponsor: University of Florida

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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 Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Facial Entropy Score From Baseline [Off Dopamine Medication]	Baseline and 4 weeks (i.e., immediate after 4-week treatment)	Primary outcome is change in entropy score from baseline to immediate completion of 4 week intervention. Entropy is a computer derived index of facial movement that is computed by quantifying changes in pixel intensity as the face moves over a series of video frames. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity (desired). In this condition ("off dopamine), entropy scores were obtained when participants were tested "off" their normal dopamine medications. Off-dopamine testing occurred after a 12-hour overnight washout period.
Change in Facial Entropy Score From Baseline [On Dopamine Medication]	Baseline and 4 weeks (i.e., immediate after 4-week intervention)	Outcome is entropy change from baseline to immediate completion of 4 week intervention when participants remained on their normal dosage of dopamine medication. Entropy is quantitative index of facial movement that is computed from changes in pixel intensity as the face moves. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity. Greater expressivity is desired outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)	Baseline and 4 weeks (i.e., immediate post-intervention)	The PDQ-39 is a widely used quality of life measure that is specific to Parkinson disease. Total raw score on the PDQ-39 ranges from 0 to 156. Higher scores reflect worse quality of life rating. Total score on PDQ-39 was used to compute pre-post treatment changes.

Trial Locations

Locations (1): Cognitive Neuroscience Laboratory, L3-135, McKnight Brain Institute, University of Florida
🇺🇸
Gainesville, Florida, United States
Cognitive Neuroscience Laboratory, L3-135, McKnight Brain Institute, University of Florida
🇺🇸Gainesville, Florida, United States