Voice Treatment for Parkinson's Disease

Study Overview
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Brief Summary
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This study addresses several issues related to the clinical management of speech and voice disorders associated with Parkinson's disease. Two behavioral treatment programs, Lee Silverman Voice Treatment and SpeechVive, are assessed in their ability to improve communication in persons with Parkinson's disease.

Detailed Description
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Surgical and pharmacological management of the motor-based symptoms of PD has made great strides over the last few decades. The behavioral management of the speech and voice symptoms however, has not grown by the same leaps and bounds. Despite the prevalence of speech and voice symptoms associated with PD, few evidence-based treatment options are currently available. In the face of good efficacy data, the Lee Silverman Voice Treatment (LSVT LOUD) program continues to be the gold standard for voice treatment. LSVT LOUD trains patients to monitor and adjust their vocal intensity when they perceive that their voice is soft. Therefore, the success of LSVT LOUD is predicated, in part, on an individual's ability to self-monitor and self-cue (internal cueing) during speech production. While LSVT LOUD has fostered significant improvements in communication for many patients with PD, not all patients respond to treatment. It has been postulated that underlying sensory and cognitive factors may hinder treatment outcomes. A new behavioral treatment for speech and voice impairment has recently been introduced. The SpeechVive, a small in-the-ear device, uses an external noise cue to elicit louder speech. While LSVT LOUD and the SpeechVive have both been shown to significantly increase sound pressure level (SPL) in patients with PD, the physiologic adjustments supporting these changes in SPL remain unclear. This is an important area of study for two reasons. First, both treatments are exercised-based programs, yet the physiologic changes associated with these treatments are not well understood. Second, there is evidence to suggest that the use of an external cue, such as the noise cue used in SpeechVive training, elicits more efficient respiratory patterns in neurologically-healthy and neurologically-involved patients, in comparison to self-initiated cueing strategies, such as those used in LSVT LOUD. This study proposes to compare the influence of cueing strategy on treatment outcomes by examining simultaneous respiratory-laryngeal adjustments before and after participation in LSVT LOUD (internal cueing) and SpeechVive (external cueing) training. It is important to study respiratory-laryngeal interactions because both of these subsystems contribute to vocal intensity regulation. In addition, exercise physiology studies have indicated that internal and external forms of cueing elicit different perceptions of physical and mental effort during exercise. It is important to understand the patients' level of perceived physical and mental effort, associated with each treatment program, as these variables can effect adherence to the treatment regime. In summary, the proposed study is intended to 1) fill a critical void in the investigator's understanding of respiratory-laryngeal adjustments used to support increased SPL under two evidence-based behavioral voice treatment programs, and 2) to better understand how patients' perceptions of physical and mental effort are shaped by each treatment paradigm. The information generated in this study could potentially lead to more efficient voice rehabilitation for persons with PD.

Official Title
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A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease

Conditions
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Idiopathic Parkinson Disease

Intervention / Treatment
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* Behavioral: Lee Silverman Voice Treatment
* Device: SpeechVive
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Parkinson's disease Problems with speech loudness due to Parkinson's disease No asthma or other respiratory problems No head, neck or chest surgery (Pacemaker surgery is okay) Non-smoking for the last 5 years Not currently participating in another treatment study Typical cognitive skills Free of symptoms of depression Unaided hearing in at least one ear No voice therapy or voice therapy maintenance within the last 12 months Exclusion Criteria: Other neurological diseases, other than Parkinson's disease History of asthma or respiratory problems Head, neck or chest surgery Smoker within the last 5 years Currently involved in another treatment study Decreased cognition Symptoms of depression Wear a hearing aid in both ears Participated in voice therapy within the last 12 months.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are stratified by voice severity and assigned to one of three groups: Lee Silverman Voice Treatment (intervention), SpeechVive (intervention), or non-treatment control group (control).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lee Silverman Voice Treatment<br>Persons with Parkinson's disease receive Lee Silverman Voice Treatment over an eight week period. Four weeks of face-to-face intervention and four weeks of home practice. | Behavioral: Lee Silverman Voice Treatment<br>* Persons with Parkinson's disease receive sixteen hours of voice treatment over a four week period. Participants will practice the vocal exercises at home for an additional four weeks.<br>|
| Experimental: SpeechVive<br>Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device. | Device: SpeechVive<br>* Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.<br>|
| Active Comparator: Control<br>Persons with Parkinsons disease do not receive voice intervention | Behavioral: Control<br>* Persons assigned to the non-treatment control group will not participate in voice treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis. | Vocal intensity (dB SPL) will be measured during a reading task and a monologue task. The vocal intensity data reported will be collapsed across the reading and monologue task. Recorded speech samples are captured using a head-mounted microphone. The speech signals are analyzed for vocal intensity using Praat. The pre- to post-treatment change in vocal intensity is reported in decibels. A positive value indicates an increase in vocal intensity post-treatment. A negative value indicates a decrease in vocal intensity post-treatment. We expected to see no change in vocal intensity for the control group as they did not receive voice intervention. | Change from baseline after 8 weeks of treatment | 
| Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics. | Changes in speech breathing will be assessed by examining movement in the ribcage and abdominal walls (respiratory kinematics) during speech. Non-invasive elasticized bands are fitted around the chest and abdominal walls to monitor movement. Respiratory kinematic measures will be in percentage of vital capacity relative to end-expiratory level. Negative values for lung volume termination indicate that speech was terminated below end-expiratory level. Positive values for lung volume termination indicate that speech was terminated above end-expiratory level. The data reported show the baseline and post-treatment values for lung volume initiation, termination, and excursion as a percentage of vital capacity relative to end-expiratory level. | Change from baseline after 8 weeks of treatment | 
| Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient) | Movement of air through the vocal folds will also be assessed during a vowel and sentence production task using a vented mask that fits over the nose and mouth. This allows us to derive estimates of how long the vocal folds are open (open quotient). Pre-treatment and post-treatment values are reported. Open quotient is a unit-less measure. | Change from baseline after 8 weeks of treatment | 
| Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index | Ratings of physical and mental effort will be assigned by participants on treatment days using the modified NASA-Task Load Index. Participants rate how much physical effort and mental effort it took to complete treatment each day. Participants will indicate their response using a visual analogue scale (0-100) with the endpoints no effort (0) to significant effort (100). Data are not reported for the clinical control group as these participants did not receive treatment. Ratings of mental and physical effort are reported separately at baseline and post-treatment. | Change from baseline after 8 weeks of treatment | 
| Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR) | Movement of air through the vocal folds will also be assessed during a vowel and sentence production task using a vented mask that fits over the nose and mouth. This allows us to derive estimates of how quickly the vocal folds are closing (maximum flow declination rate). Pre-treatment and post-treatment values are reported. Maximum flow declination rate (MFDR) is reported in liters per second per second (L/s/s). | Change from baseline after 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39) | This 39-item self-report questionnaire is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. The PDQ-39 scores each item on a 5 point scale (0=never, 4=always) and is scored along 8 different scales: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. A summary index score is calculated by averaging the scores across these 8 difference scales. The minimum score is 0 and the maximum score is 100. Lower scores indicate a better quality of life and higher scores indicate a lower quality of life. Summary index scores are reported for baseline and post-treatment. | Change from baseline after 8 weeks of treatment | 
| Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire | The Communicative Participation Item Bank-Short Form is a 10-item self-report questionnaire that examines how a given condition (e.g. Parkinson's disease) interferes with communication in various situations (e.g. noisy environment). The questionnaire has 10 questions that depict a variety of speaking situations. Each of the 10 questions is assigned a score between 0 (very much) to 3 (not at all). Participants are asked to indicate how much their condition interferes with participation in each situation. The scores are summed to come up with a summary score between 0 and 30. High scores indicate less interference in participation. | Change from baseline after 8 weeks of treatment | 
| Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire | The Voice-related Quality of Life VR-QOL instrument is a 10-item self-report questionnaire that examines the impact of a persons voice impairment on activities of daily living. For each item, participants assign a score between 1 (Not a problem) and 5 (Problem is as bad as can be). A total score is calculated by summing the assigned scores across the 10 items. The minimum total score is 10 and the maximum total score is 50. Higher scores indicate that the voice problem interferes with activities of daily living. The overall VR-QOL score ranges from 10 to 15 (excellent), 16 to 20 (very good), 21 to 25 (good), 26-30 (fair) and scores more than 30 and up to 50 is poor. | Change from baseline after 8 weeks of treatment | 
| Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis. | While wearing a microphone, participants will read a short passage. The speech samples will be analyzed for speech rate using an acoustic software program. Speech rate is measured and reported in syllables per second. Higher values indicate a faster speech rate and lower values indicate a slower speech rate. | Change from baseline after 8 weeks of treatment | 
| Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis. | While wearing a microphone, participants will read a short passage. These recorded speech samples will be analyzed for the frequency of pauses using an acoustic analysis software program. Pauses are reported as a frequency count (how many occur in a given sample). | Change from baseline after 8 weeks of treatment |