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Efficacy of Voice Treatment for Parkinson's Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by University of Colorado, Boulder.
Recruitment status was:  Recruiting
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:
University of Colorado, Boulder Identifier:
First received: July 20, 2005
Last updated: May 6, 2011
Last verified: May 2011
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 Intervention Phase
Parkinson's Disease Dysphagia Dysarthria Behavioral: Voice/Respiration Treatment Behavioral: Speech/Articulation Treatment Behavioral: No intervention (PD) Behavioral: HC control Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Voice Treatment for Parkinson's Disease

Resource links provided by NLM:

Further study details as provided by University of Colorado, Boulder:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 620
Study Start Date: March 2002
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Experimental: 2 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.
No Intervention: 3 Behavioral: No intervention (PD)
Subjects with PD in the no intervention group will receive no therapy during the study. Subjects will receive therapy after completion of the study.
No Intervention: 4 Behavioral: HC control
Subjects without PD in the HC control group will not receive any therapy, either during or after completion of the study.

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.



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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00123084

Contact: Heather L Gustafson, MA, CCC-SLP 303-534-0324

United States, Colorado
National Center for Voice and Speech-Denver; An Affiliate of the unniversity of Colorado Recruiting
Denver, Colorado, United States, 80204
Contact: Heather Gustafson, MA, CCC-SLP    303-534-0324   
United States, Texas
University of Texas HSC San Antonio Recruiting
San Antonio, Texas, United States
Sub-Investigator: Peter Fox, PhD         
Sponsors and Collaborators
University of Colorado, Boulder
National Institute on Deafness and Other Communication Disorders (NIDCD)
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
  More Information

Additional Information:
Responsible Party: Dr. Lorraine Ramig, Professor, University of Colorado, Boulder Identifier: NCT00123084     History of Changes
Other Study ID Numbers: R01DC001150 ( U.S. NIH Grant/Contract )
Study First Received: July 20, 2005
Last Updated: May 6, 2011

Keywords provided by University of Colorado, Boulder:
Parkinson's disease
Swallowing difficulties

Additional relevant MeSH terms:
Articulation Disorders
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms processed this record on August 17, 2017