Clinical trial NCT03700684: Voice Treatment for Parkinson's Disease
Official title: A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Parkinson Disease
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Purdue University
First posted: 2018-10-09
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis.
timeFrame: Change from baseline after 8 weeks of treatment
measure: Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
timeFrame: Change from baseline after 8 weeks of treatment
measure: Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient)
timeFrame: Change from baseline after 8 weeks of treatment
measure: Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index
timeFrame: Change from baseline after 8 weeks of treatment
measure: Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR)
timeFrame: Change from baseline after 8 weeks of treatment
Secondary outcomes:
measure: Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Change from baseline after 8 weeks of treatment
measure: Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire
timeFrame: Change from baseline after 8 weeks of treatment
measure: Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire
timeFrame: Change from baseline after 8 weeks of treatment
measure: Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis.
timeFrame: Change from baseline after 8 weeks of treatment
measure: Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis.
timeFrame: Change from baseline after 8 weeks of treatment
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
city: Amherst
country: United States
facility: University of Massachusetts Amherst
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Kelly Richardson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.