Parkinson's DiseasePhase 2NCT00350402

Masked Faces in Parkinson Disease: Mechanism and Treatment

A Phase 2 study testing Respiratory muscle strength training in people with Parkinson's Disease, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 45 to 80 years
Conditions the study is for: Parkinson's Disease
What is being tested?: Respiratory muscle strength training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Dec 2004to Nov 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Cognitive Neuroscience Laboratory, L3-135, McKnight Brain Institute, University of Florida
Gainesville, Florida, 32601

Other trials in United States

About this study

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

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.

Read the 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
Being tested: Respiratory muscle strength training
Keywords: Parkinson's disease, PD, masked faces, diminished facial expressivity, diminished facial expression, high intensity respiratory muscle strength training, MST
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Respiratory muscle strength trainingBehavioural
Also called Respiratory Training, Inspiratory Training, Expiratory 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.

Study groups in NCT00350402
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Respiratory muscle strength training

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004Nov 2009

First posted10 Jul 2006 (estimated)
Study startDec 2004
Primary completionNov 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00350402
Sponsor's protocol ID: R01NS050633
Other IDs: R01NS050633
Status last verified: Apr 2012
First submitted: 5 Jul 2006
Last updated: 6 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00350402
Acronym / sponsor ID: R01NS050633
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, PD, masked faces, diminished facial expressivity, diminished facial expression, high intensity respiratory muscle strength training, MST
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Dec 2004
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 10 Jul 2006 (estimated)
Results: Posted 4 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
High Intensity Muscle Strength Training	Active comparator	Behavioral: Respiratory muscle strength trainingThis 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.
Sham MST	Sham comparator	Behavioral: Respiratory muscle strength trainingThis 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.

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Respiratory muscle strength trainingAlso: Respiratory Training, Inspiratory Training, Expiratory TrainingThe 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.	Behavioural	High Intensity Muscle Strength Training, Sham MST

Primary outcome

Change in Facial Entropy Score From Baseline [Off Dopamine Medication]
Time frame: 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]
Time frame: 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.

1 secondary outcome

Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)
Time frame: Baseline and 4 weeks (i.e., immediate post-intervention)

Results and safety

Results posted to the registry on 4 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inspiratory Muscle Strength Training (IMST)	21	20
Sham MST	21	20

Primary outcome: Change in Facial Entropy Score From Baseline [Off Dopamine Medication]

Time frame: Baseline and 4 weeks (i.e., immediate after 4-week treatment). Mean (Standard Deviation). Unit: units on a scale

Measure	Inspiratory Muscle Strength Training (IMST): 75% MIP n = 20	Sham IMST: 5% MIP n = 20
Value	5.649 (6.66)	-1.605 (6.16)

Inspiratory Muscle Strength Training (IMST): 75% MIP vs Sham IMST: 5% MIP: Mean Difference (Final Values): 7.254 (95% CI 3.147 to 11.362), p < 0.001, t-test, 2 sided

Population analysed: All participants who completed baseline, intervention, and post-testing. Two participants, one from each group, dropped out during first week of intervention.

Primary outcome: Change in Facial Entropy Score From Baseline [On Dopamine Medication]

Time frame: Baseline and 4 weeks (i.e., immediate after 4-week intervention). Mean (Standard Deviation). Unit: Units on a scale

Measure	Inspiratory Muscle Strength Training (IMST): 75% MIP n = 20	Sham IMST: 5% MIP n = 20
Value	3.559 (9.995)	-1.569 (4.931)

Inspiratory Muscle Strength Training (IMST): 75% MIP vs Sham IMST: 5% MIP: Mean Difference (Final Values): 5.129 (95% CI .0834 to 10.17), p <0.047, t-test, 2 sided

Population analysed: Based on individuals who completed baseline and post-treatment assessment following 4 weeks of intervention. One individual from each treatment group dropped out during the first week of intervention and were not included in analyses.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data collected for 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inspiratory Muscle Strength Training (IMST)	0 of 21 (0%)	0 of 21 (0%)	Not reported
Sham MST	0 of 21 (0%)	0 of 21 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dawn Bowers, Ph.D. principal investigator

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

Christine Sapienza, Ph.D. principal investigator

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

Michael S. Okun, M.D. principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Respiratory muscle strength training in people with Parkinson's Disease, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Facial Entropy Score From Baseline [Off Dopamine Medication] (time frame: Baseline and 4 weeks (i.e., immediate after 4-week treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00350402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.