Masked Faces in Parkinson Disease: Mechanism and Treatment

NCT ID: NCT00350402

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2009-11-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Respiratory muscle strength training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: SHAM_COMPARATOR

Respiratory muscle strength training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Respiratory Training; Inspiratory Training; Expiratory Training

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn Bowers, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor and Area Head, Department of Clinical and Health Psychology, University of Florida

Christine Sapienza, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor and Chair, Department of Communication Sciences and Disorders, University of Florida

Michael S. Okun, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Co-Director Movement Disorders Program, Medical Director, National Parkinson Foundation, Department of Neurology

Hubert Fernandez, M.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor and Director of Clinical Trials, Movement Disorder Program, Department of Neurology, University of Florida

Locations

Cognitive Neuroscience Laboratory, L3-135, McKnight Brain Institute, University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

R01NS050633

Identifier Type: NIH

Identifier Source: secondary_id

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R01NS050633

Identifier Type: NIH

Identifier Source: org_study_id

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