Masked Faces in Parkinson Disease: Mechanism and Treatment

NCT00350402 | Completed Phase 2 Results DMC

• 1 other identifier: R01NS050633
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; PD; masked faces; diminished facial expressivity; diminished facial expression; high intensity respiratory muscle strength training; MST

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (1)

• Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)

  Baseline and 4 weeks (i.e., immediate post-intervention)

Other Outcomes (1)

• Change From Baseline in Maximal Inspiratory Pressure (MIP)

  Baseline and 4 weeks (i.e., immediate after 4-week intervention)

Study Arms (2)

High Intensity Muscle Strength Training

ACTIVE COMPARATOR

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

Sham MST

SHAM COMPARATOR

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

Interventions

Respiratory muscle strength training 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.

Also known as: Respiratory Training, Inspiratory Training, Expiratory Training

High Intensity Muscle Strength Training; Sham MST

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

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

Gainesville, Florida, 32601, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Dawn Bowers
• Organization: University of Florida

dawnbowers@phhp.ufl.edu

(352) 392-3450

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: December 1, 2004
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 6, 2012
• Results First Posted: April 4, 2012

Record last verified: 2012-04

Locations

US (1)