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Efficacy of Voice Treatment for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123084
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Colorado, Boulder

Brief Summary:
The purpose of the research study is to determine the effects of two different kinds of speech treatment on certain behaviors in individuals with parkinson's disease. These behaviors include speech, voice, related communication behaviors, swallowing and body movement.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Dysphagia Dysarthria Behavioral: Voice/Respiration Treatment Behavioral: Speech/Articulation Treatment Not Applicable

Detailed Description:

This is a research project designed to look at various areas of function, such as speech, voice, swallowing, related communication behaviors and body movement of individuals with idiopathic Parkinson disease (PD) and to investigate how two different forms of speech therapy affect these areas.

We are asking up to 620 individuals to participate in this study in several different ways. Specifically, there is an experimental group (ExpG), questionnaire group (QG) and communication partner group (CPG). The ExpG will be composed of individuals with PD and the healthy age and gender matched controls (HC)(Up to 140 total will be asked, 80 expected to complete the study). The QG will include the significant others, family members, and friends of the ExpG (Up to 140 will be asked, 80 expected to complete the study). The CPG will be made up of friends of the ExpG (Up to 340 will be asked, 240 expected to complete the study).Some individuals in the ExpG may not pass the initial screenings. As a result, their QG and CPG will no longer need to participate. Therefore, the actual number of individuals who will complete the study is expected to be much less.

There are 10 PHASES of this study. The initial PHASES (1,2,3) are screening PHASES to determine if the individual is a good candidate for this study. PHASES 4, 6 and 10 are PHASES of recording data and PHASE 5 is treatment. PHASES 7, 8 and 9 are additional assessments. The total duration of the Subjects (Ss) participation from the time Ss sign the consent to the completion of the last phase (PHASE 10) is approximately10 months.

PHASE 1: ENT/CLINICAL VOICE AND SPEECH SCREEN PHASE 2: SWALLOW SCREEN AND ASSESSMENT PHASE 3: THINKING SKILLS SCREEN AND ASSESSMENT After the completion of PHASES 1-3, the research team will look at the data collected and determine if the Ss meet the criteria to participate in this study. If asked to participate, Ss will be assigned to one of four groups and then continue with PHASE 4.

PHASE 4: INITIAL DATA RECORDINGS All of the procedures in PHASE 4 will be done two times before the treatment PHASE 5. Each recording will take approximately 2-2.5 hours.

PHASE 5: TREATMENT PHASE 6: POST TREATMENT PHASE DATA RECORDINGS PHASE 7: FOLLOW-UP ENT EVALUATION PHASE 8: FOLLOW-UP SWALLOW EVALUATION PHASE 9: FOLLOW-UP THINKING SKILLS EVALUATION PHASE 10: 6-MONTH POST TREATMENT PHASE DATA RECORDINGS

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Voice Treatment for Parkinson's Disease
Study Start Date : March 2002
Actual Primary Completion Date : September 30, 2012
Actual Study Completion Date : September 30, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Voice/Respiratory Treatment
4 Days a week for 4 weeks with focus on high intensity voice exercises
Behavioral: Voice/Respiration Treatment
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort exercises focusing on increased loudness and good voice quality.
Other Name: LSVT LOUD

Experimental: Articulation Treatment
4 days a week for 4 weeks with focus on high intensity articulation tasks
Behavioral: Speech/Articulation Treatment
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech.
Other Name: LSVT ARTIC

No Intervention: Subjects with PD in a no treatment group
Subjects do not receive therapy during experimental phases, and will be offered therapy at the end of the study enrollment period.
No Intervention: Healthy Control Subjects
Subjects are without Parkinson disease and will not receive therapy.



Primary Outcome Measures :
  1. Voice intensity; voice fundamental frequency; articulatory acoustics; physiological voice function; speech intelligibility; swallowing function; non-verbal communication behaviors; limb function; neural imaging; neuropsychological functioning [ Time Frame: 8-9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's Disease (IPD)
  • None or mild dementia
  • None, mild or moderate depression
  • Mild, moderate or severe speech, voice, and swallowing disorder

Exclusion Criteria:

  • Severe depression
  • Moderate or severe dementia
  • Symptoms of another neurological condition other than or in addition to IPD or drug abuse
  • Head or neck cancer
  • Significant history of gastrointestinal disease or surgery
  • Speech or voice disorders unrelated to IPD
  • Neurosurgery, not for management of PD symptoms
  • Laryngeal pathology/surgery
  • Full-course Lee Silverman Voice Treatment (LSVT®)
  • Smoked in last four years
  • Absence of speech, voice or swallowing disorder
  • Severe temporomandibular joint disorder
  • Pregnancy (or the possibility of pregnancy)
  • Hearing loss unexpected for his/her chronological age

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): NCT00123084


Locations
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United States, Colorado
National Center for Voice and Speech-Denver; An Affiliate of the unniversity of Colorado
Denver, Colorado, United States, 80204
United States, Texas
University of Texas HSC San Antonio
San Antonio, Texas, United States
Sponsors and Collaborators
University of Colorado, Boulder
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Lorraine Ramig, PhD, CCC-SLP Professor, University of Colorado-Boulder; Senior Scientist, National Center for Voice and Speech-Denver; Adjunct Professor, Columbia University-NYC
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT00123084    
Other Study ID Numbers: R01DC001150 ( U.S. NIH Grant/Contract )
R01DC001150 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: April 2017
Keywords provided by University of Colorado, Boulder:
Parkinson's disease
Swallowing difficulties
speech
voice
Additional relevant MeSH terms:
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Parkinson Disease
Dysarthria
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Articulation Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations