Voice Treatment for Parkinson's Disease

NCT ID: NCT03700684

Last Updated: 2023-05-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2022-11-30

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.

Conditions

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Idiopathic Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Data files are coded to mask group assignment, session ID, and testing condition.

Study Groups

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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.

Group Type EXPERIMENTAL

Lee Silverman Voice Treatment

Intervention Type BEHAVIORAL

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.

SpeechVive

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

Group Type EXPERIMENTAL

SpeechVive

Intervention Type DEVICE

Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.

Control

Persons with Parkinsons disease do not receive voice intervention

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Persons assigned to the non-treatment control group will not participate in voice treatment.

Interventions

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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.

Intervention Type BEHAVIORAL

SpeechVive

Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.

Intervention Type DEVICE

Control

Persons assigned to the non-treatment control group will not participate in voice treatment.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role lead

Responsible Party

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Kelly Richardson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kelly Richardson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Amherst

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

University of Massachusetts Amherst

Amherst, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 24438910 (View on PubMed)

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.

Reference Type RESULT
PMID: 25459460 (View on PubMed)

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.

Reference Type RESULT
PMID: 21386044 (View on PubMed)

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.

Reference Type RESULT
PMID: 17266087 (View on PubMed)

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.

Reference Type RESULT
PMID: 20844256 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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1R21DC016718-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-4212

Identifier Type: -

Identifier Source: org_study_id

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