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Efficacy of Voice Treatment for Parkinson's Disease
This study is currently recruiting participants.
Study NCT00123084   Information provided by National Institute on Deafness and Other Communication Disorders (NIDCD)
First Received: July 20, 2005   Last Updated: May 18, 2009   History of Changes

July 20, 2005
May 18, 2009
March 2002
May 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Voice intensity; voice fundamantal 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00123084 on ClinicalTrials.gov Archive Site
 
 
 
Efficacy of Voice Treatment for Parkinson's Disease
Efficacy of Voice Treatment for Parkinson's Disease

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.

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

Phase II
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
  • Parkinson's Disease
  • Dysphagia
  • Dysarthria
  • Behavioral: Voice/Respiration Treatment
  • Behavioral: Speech/Articulation Treatment
  • Behavioral: No intervention (PD)
  • Behavioral: HC control
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
620
December 2012
May 2011   (final data collection date for primary outcome measure)

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
Both
45 Years to 85 Years
Yes
Contact: Heather L Gustafson, MA, CCC-SLP 303-893-6025 hgustafson@dcpa.org
United States
 
NCT00123084
Dr. Lorraine Ramig, Professor, University of Colorado, Boulder
R01 DC01150
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
National Institute on Deafness and Other Communication Disorders (NIDCD)
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP