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Voice Treatment for Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03700684
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Purdue University
Information provided by (Responsible Party):
Kelly Richardson, University of Massachusetts, Amherst

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson Disease Behavioral: Lee Silverman Voice Treatment Device: SpeechVive Behavioral: Control Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: Data files are coded to mask group assignment, session ID, and testing condition.
Primary Purpose: Treatment
Official Title: A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lee Silverman Voice Treatment
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
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.

Experimental: SpeechVive
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
Device: SpeechVive
Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.

Active Comparator: Control
Persons with Parkinsons disease do not receive voice intervention
Behavioral: Control
Persons assigned to the non-treatment control group will not participate in voice treatment.




Primary Outcome Measures :
  1. Treatment-related changes in speech breathing will be assessed using respiratory kinematics and laryngeal aerodynamics. [ Time Frame: Change from baseline after 8 weeks of treatment ]
    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 expressed in volts. Movement of air through the vocal folds will also be assessed during speech using a vented mask that fits over the nose and mouth (laryngeal aerodynamics). This allow us to derive estimates of how long the vocal folds are open (open quotient) and how quickly they are closing (maximum flow declination rate).

  2. Assessing mental and physical effort associated with each treatment program using the modified National Aeronautics and Space Administration (NASA)-Task Load Index [ Time Frame: Change from baseline after 8 weeks of treatment ]
    Ratings of physical and mental effort will be assigned by participants on treatment days using the modified NASA-Task Load Index. Participants will rate how much physical effort and mental effort it took to complete treatment that day. Participants will indicate their response using a visual analogue scale with the endpoints "no effort" "significant effort".

  3. Treatment-related changes in vocal intensity will be assessed using acoustic analysis. [ Time Frame: Change from baseline after 8 weeks of treatment ]
    Vocal intensity (dB SPL) will be measured during a reading task and a monologue task. Recorded speech samples are captured using a head-mounted microphone. The speech signals are analyzed for vocal intensity using acoustic software programs. Higher values of vocal intensity represent a louder speaking volume.


Secondary Outcome Measures :
  1. Treatment-related changes in quality of life will be assessed using the Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Change from baseline after 8 weeks of treatment ]
    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 (1=never, 5=always) and is scored along 8 discrete 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 obtained across the 8 discrete scales. For the discrete scales and the summary score, lower scores represent a better quality of life.

  2. Treatment-related changes in communicative competence will be assessed using the Communicative Participation Item Bank-Short Form Questionnaire [ Time Frame: Change from baseline after 8 weeks of treatment ]
    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.

  3. Treatment-related changes in activities of daily living assessed by the Voice-related Quality of Life (V-RQOL) Questionnaire [ Time Frame: Change from baseline after 8 weeks of treatment ]
    The Voice-related Quality of Life 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. Higher scores indicate that the voice problem interferes with activities of daily living.

  4. Treatment-related changes in spoken language will be assessed using a narrative analysis. [ Time Frame: Change from baseline after 8 weeks of treatment ]
    Participants are asked to tell a story about the people and events depicted in a picture array. The recorded speech sample is analyzed to assess expressive language skills including measures of pause duration and syntactic structure.

  5. Treatment-related changes in speech rate will be assessed using acoustic analysis. [ Time Frame: Change from baseline after 8 weeks of treatment ]
    While wearing a microphone, participants will read a short passage and provide a monologue on a topic of their choice. These recorded 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.

  6. Treatment-related changes in speech pauses will be assessed using acoustic analysis. [ Time Frame: Change from baseline after 8 weeks of treatment ]
    While wearing a microphone, participants will read a short passage and provide a monologue on a topic of their choice. These recorded speech samples will be analyzed for filled and unfilled pauses using an acoustic software program. Pauses are reported as a frequency count (how many occur in a given sample) and the average duration of the pauses (in msec).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700684


Contacts
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Contact: Kelly Richardson, Ph.D. 413-545-2007 krichardson@comdis.umass.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Jessica Huber, Ph.D.    765-494-3796    jhuber@purdue.edu   
Contact: Sandy Snyder    765-494-6488    snyder33@purdue.edu   
United States, Massachusetts
University of Massachusetts Amherst Recruiting
Amherst, Massachusetts, United States, 01040
Contact: Kelly Richardson, Ph.D.         
Sponsors and Collaborators
University of Massachusetts, Amherst
National Institute on Deafness and Other Communication Disorders (NIDCD)
Purdue University
Investigators
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Principal Investigator: Kelly Richardson, Ph.D. University of Massachusetts, Amherst
Publications of Results:
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Responsible Party: Kelly Richardson, Assistant Professor, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT03700684    
Other Study ID Numbers: 2017-4212
1R21DC016718-01 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data from the persons with Parkinson's disease will include perceptions of physical and mental effort, objective measures of speech, voice, and respiratory function.
Time Frame: Data will become available once it has been deidentified and published in peer-reviewed journals.
Access Criteria:

Any researcher requesting access to these data will need to submit to Kelly Richardson the following:

  1. Name and institution of PI
  2. Proof of institutional appointment
  3. Names and roles for all individuals who will access the data for the planned analysis
  4. Detailed plan for the use of the data
  5. Timeline for the use and publication of the analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases