Masked Faces in Parkinson Disease: Mechanism and Treatment

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350402
• Other study ID #: R01NS050633
• Secondary ID: R01NS050633
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2006
• Last updated: April 4, 2012
• Start date: December 2004
• Est. completion date: November 2009

Study information

• Verified date: April 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Respiratory muscle strength training
The Muscle Stength Training (MST)device is a mouthpiece that the participant uses to inspire against controlled resistance; Intervention involves use of this device for breathing exercises over 4 week period, 5 days a week, approximately 20 minutes/day.

Locations

Country	Name	City	State
United States	Cognitive Neuroscience Laboratory, L3-135, McKnight Brain Institute, University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Facial Entropy Score From Baseline [Off Dopamine Medication]	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.	Baseline and 4 weeks (i.e., immediate after 4-week treatment)	No
Primary	Change in Facial Entropy Score From Baseline [On Dopamine Medication]	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.	Baseline and 4 weeks (i.e., immediate after 4-week intervention)	No
Secondary	Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)	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.	Baseline and 4 weeks (i.e., immediate post-intervention)	No