Masked Faces in Parkinson Disease: Mechanism and Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00350402
First received: July 5, 2006
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Behavioral: Respiratory muscle strength training
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in Facial Entropy Score From Baseline [Off Dopamine Medication] [ Time Frame: Baseline and 4 weeks (i.e., immediate after 4-week treatment) ] [ Designated as safety issue: No ]
    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] [ Time Frame: Baseline and 4 weeks (i.e., immediate after 4-week intervention) ] [ Designated as safety issue: No ]
    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:
  • Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39) [ Time Frame: Baseline and 4 weeks (i.e., immediate post-intervention) ] [ Designated as safety issue: No ]
    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.


Enrollment: 44
Study Start Date: December 2004
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High Intensity Muscle Strength Training
This arm involved high intensity muscle strength training at 75% maximum inspiratory pressure (MIP). Training took place for 4 weeks, 5 days a week. Each daily session involved 5 sets of breathing exercises that required participants to take deep breaths (i.e., inspire) using use a breathing device. Settings on the breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP)using a specialized breathing gauge. The MIP was determined at the beginning of each week and the training device was adjusted and set at 75% MIP. Exercises took place in home setting, with weekly visit by staff. Participants kept daily exercise log.
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.
Other Names:
  • Respiratory Training
  • Inspiratory Training
  • Expiratory Training
Sham Comparator: Sham MST
This arm (low intensity MST) was identical to the real intervention in all ways except that the training device was set at 5% maximum inspiratory pressure (MIP). Thus less muscle and breathing effort was required during this sham treatment.
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.
Other Names:
  • Respiratory Training
  • Inspiratory Training
  • Expiratory Training

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

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350402

Locations
United States, Florida
Cognitive Neuroscience Laboratory, L3-135, McKnight Brain Institute, University of Florida
Gainesville, Florida, United States, 32601
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Dawn Bowers, Ph.D. Professor and Area Head, Department of Clinical and Health Psychology, University of Florida
Principal Investigator: Christine Sapienza, Ph.D. Professor and Chair, Department of Communication Sciences and Disorders, University of Florida
Principal Investigator: Michael S. Okun, M.D. Assistant Professor, Co-Director Movement Disorders Program, Medical Director, National Parkinson Foundation, Department of Neurology
Principal Investigator: Hubert Fernandez, M.D. Associate Professor and Director of Clinical Trials, Movement Disorder Program, Department of Neurology, University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00350402     History of Changes
Other Study ID Numbers: R01NS050633, R01NS050633
Study First Received: July 5, 2006
Results First Received: February 6, 2012
Last Updated: April 4, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Florida:
Parkinson's disease
PD
masked faces
diminished facial expressivity
diminished facial expression
high intensity respiratory muscle strength training
MST

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014