Efficacy of Voice Treatment for Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Efficacy of Voice Treatment for Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123084
• Other study ID #: R01DC001150
• Secondary ID: R01DC001150
• Status: Completed
• Phase: N/A
• Start date: March 2002
• Est. completion date: September 30, 2012

Study information

• Verified date: April 2017
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: September 30, 2012
• Est. primary completion date: September 30, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysarthria
• Dysphagia
• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	National Center for Voice and Speech-Denver; An Affiliate of the unniversity of Colorado	Denver	Colorado
United States	University of Texas HSC San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Boulder	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voice intensity; voice fundamental frequency; articulatory acoustics; physiological voice function; speech intelligibility; swallowing function; non-verbal communication behaviors; limb function; neural imaging; neuropsychological functioning		8-9 months

External Links

•   Click here for more information about this study: Efficacy of Voice Treatment for individuals with Parkinson's disease at the National Center for Voice and Speech