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Voice Treatment for Parkinson's Disease

Primary Purpose

Idiopathic Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lee Silverman Voice Treatment
SpeechVive
Control
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Purdue University
  • University of Massachusetts Amherst

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Lee Silverman Voice Treatment

SpeechVive

Control

Arm Description

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.

Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.

Persons with Parkinsons disease do not receive voice intervention

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).

Secondary Outcome Measures

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.
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.
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.
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.
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).

Full Information

First Posted
October 4, 2018
Last Updated
May 2, 2023
Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT03700684
Brief Title
Voice Treatment for Parkinson's Disease
Official Title
A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Purdue University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Data files are coded to mask group assignment, session ID, and testing condition.
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lee Silverman Voice Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
SpeechVive
Arm Type
Experimental
Arm Description
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Persons with Parkinsons disease do not receive voice intervention
Intervention Type
Behavioral
Intervention Name(s)
Lee Silverman Voice Treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SpeechVive
Intervention Description
Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Persons assigned to the non-treatment control group will not participate in voice treatment.
Primary Outcome Measure Information:
Title
Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis.
Description
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.
Time Frame
Change from baseline after 8 weeks of treatment
Title
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
Description
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.
Time Frame
Change from baseline after 8 weeks of treatment
Title
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient)
Description
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.
Time Frame
Change from baseline after 8 weeks of treatment
Title
Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index
Description
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.
Time Frame
Change from baseline after 8 weeks of treatment
Title
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR)
Description
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).
Time Frame
Change from baseline after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39)
Description
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.
Time Frame
Change from baseline after 8 weeks of treatment
Title
Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire
Description
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.
Time Frame
Change from baseline after 8 weeks of treatment
Title
Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire
Description
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.
Time Frame
Change from baseline after 8 weeks of treatment
Title
Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis.
Description
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.
Time Frame
Change from baseline after 8 weeks of treatment
Title
Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis.
Description
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).
Time Frame
Change from baseline after 8 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Richardson, Ph.D.
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
Facility Name
University of Massachusetts Amherst
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01040
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will become available once it has been deidentified and published in peer-reviewed journals.
IPD Sharing Access Criteria
Any researcher requesting access to these data will need to submit to Kelly Richardson the following: Name and institution of PI Proof of institutional appointment Names and roles for all individuals who will access the data for the planned analysis Detailed plan for the use of the data Timeline for the use and publication of the analysis.
Citations:
PubMed Identifier
24438910
Citation
Stathopoulos ET, Huber JE, Richardson K, Kamphaus J, DeCicco D, Darling M, Fulcher K, Sussman JE. Increased vocal intensity due to the Lombard effect in speakers with Parkinson's disease: simultaneous laryngeal and respiratory strategies. J Commun Disord. 2014 Mar-Apr;48:1-17. doi: 10.1016/j.jcomdis.2013.12.001. Epub 2013 Dec 28.
Results Reference
result
PubMed Identifier
25459460
Citation
Richardson K, Sussman JE, Stathopoulos ET. The effect of increased vocal intensity on interarticulator timing in speakers with Parkinson's disease: a preliminary analysis. J Commun Disord. 2014 Nov-Dec;52:44-64. doi: 10.1016/j.jcomdis.2014.09.004.
Results Reference
result
PubMed Identifier
21386044
Citation
Darling M, Huber JE. Changes to articulatory kinematics in response to loudness cues in individuals with Parkinson's disease. J Speech Lang Hear Res. 2011 Oct;54(5):1247-59. doi: 10.1044/1092-4388(2011/10-0024). Epub 2011 Mar 8.
Results Reference
result
PubMed Identifier
17266087
Citation
Sadagopan N, Huber JE. Effects of loudness cues on respiration in individuals with Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):651-9. doi: 10.1002/mds.21375.
Results Reference
result
PubMed Identifier
20844256
Citation
Huber JE, Darling M. Effect of Parkinson's disease on the production of structured and unstructured speaking tasks: respiratory physiologic and linguistic considerations. J Speech Lang Hear Res. 2011 Feb;54(1):33-46. doi: 10.1044/1092-4388(2010/09-0184). Epub 2010 Sep 15.
Results Reference
result

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Voice Treatment for Parkinson's Disease

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