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

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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title: Efficacy of Voice Treatment for Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

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 ] [ Designated as safety issue: No ]

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
1: Experimental 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.
2: Experimental 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.
3: No Intervention 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.
4: No Intervention 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.

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

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123084

Contacts
Contact: Heather L Gustafson, MA, CCC-SLP 303-893-6025 hgustafson@dcpa.org

Locations
United States, Colorado
National Center for Voice and Speech, Division of the Denver Center for the Performing Arts Recruiting
Denver, Colorado, United States, 80204
Contact: Heather Gustafson, MA, CCC-SLP     303-893-6025     pdresearch@dcpa.org    
United States, Texas
University of Texas HSC San Antonio Recruiting
San Antonio, Texas, United States
Sub-Investigator: Peter Fox, PhD            
Sponsors and Collaborators
Investigators
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:
No publications provided

Responsible Party: University of Colorado, Boulder ( Dr. Lorraine Ramig, Professor )
Study ID Numbers: R01 DC01150
Study First Received: July 20, 2005
Last Updated: May 18, 2009
ClinicalTrials.gov Identifier: NCT00123084     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
Parkinson's disease
Swallowing difficulties
speech
voice

Study placed in the following topic categories:
Speech Disorders
Ganglion Cysts
Otorhinolaryngologic Diseases
Gastrointestinal Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Language Disorders
Neurodegenerative Diseases
Brain Diseases
Pharyngeal Diseases
Deglutition Disorders
Signs and Symptoms
Digestive System Diseases
Esophageal Disorder
Movement Disorders
Parkinson Disease
Dysarthria
Neurologic Manifestations
Articulation Disorders
Parkinsonian Disorders
Esophageal Diseases
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:
Speech Disorders
Otorhinolaryngologic Diseases
Gastrointestinal Diseases
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Language Disorders
Neurodegenerative Diseases
Brain Diseases
Pharyngeal Diseases
Deglutition Disorders
Signs and Symptoms
Digestive System Diseases
Movement Disorders
Parkinson Disease
Dysarthria
Neurologic Manifestations
Articulation Disorders
Parkinsonian Disorders
Esophageal Diseases
Neurobehavioral Manifestations
Communication Disorders

ClinicalTrials.gov processed this record on July 06, 2009