Phase 2
Completed N=42
Masked Faces in Parkinson Disease: Mechanism and Treatment
Source: ClinicalTrials.gov NCT00350402 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcomePrimary: Change in Facial Entropy Score From Baseline [Off Dopamine Medication] — 5.649; -1.605 units on a scale — p=< 0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Facial Entropy Score From Baseline [Off Dopamine Medication] |
5.649; -1.605 | < 0.001 sig |
| PRIMARY Change in Facial Entropy Score From Baseline [On Dopamine Medication] |
3.559; -1.569 | <0.047 sig |
| SECONDARY Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39) |
1.850; -1.550 | <0.459 |
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)
Data sourced from ClinicalTrials.gov (NCT00350402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.