• PDtrials - Parkinson's Disease Clinical Trials
• /Browse All Trials

Official Study Title: Efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. of Voice Treatment for Parkinson's Disease
Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)
Clinicaltrials.gov ID: NCT00123084
Study ID: COMIRB #00-606, UCB HRC #1000.22

Summary

The purpose of this study is to determine the effects of two different kinds of speech treatment on certain behaviors in individuals with Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD). These behaviors include speech, voice, swallowing, related communication behaviors and body movement. Communication difficulties are very common in people with PD. This study will help us understand which kinds of speech treatment are the most helpful for individuals with PD, and to understand how treatment can affect other areas of behavior as well. After five initial assessments are completed, participants will be randomly assigned to one of two speech treatment groups or a non-treatment PD control group.  Control Group (Comparison Group)Clinical trial participants who are given either a standard treatment or a placebo instead of the investigational drug or treatment being tested. If placed in a treatment group volunteers will participate in 16-1 hour treatment sessions in one month. The treatment sessions will focus on improving voice and speech. After the four weeks of treatment are completed, all three groups will be asked to participate in five follow-up assessments spread over two weeks. Six-months after the treatment phase participants will be asked to come back for two follow-up visits. Participation is voluntary. Participants will be compensated for their participation. All assessments and treatment will be provided at no cost.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Swallowing difficulty, Speech problems (hypophonic)  HypophonicRelating to hypophonia, or the reduction in the volume and clarity of one's voice. , Masked Face  Masked FaceLoss of facial expression and reduced blink rate and eye movement make a person appear to be staring off in the distance, which can be misinterpreted as lack of interest or depression.

Time Commitment

• More than six months
• Approximately 28 visits over 8 months

Eligibility

• Minimum Age: 45
• Maximum Age: 85
• Gender(s) Accepted: Either
• Study is enrolling non-PD participants

Inclusion Criteria

• Age 45 to 85
• Diagnosis of Parkinson's disease
• Mild, moderate or severe speech, voice, and swallowing disorder
• Individuals without PD, who do not have any voice, speech, swallowing difficulties, are also needed to serve as a comparison group to the PD group

Exclusion Criteria

• Absence of speech, voice or swallowing disorder
• Participation in intensive speech treatment within the last four years
• Smoked within last four years

Enrollment

Expected Enrollment: 500 (US)
Date Enrollment Began: Aug 2004
Date Enrollment Ends: Aug 2004
Last Updated Date: Sep 25 2008
Trial Post Date: Jan 18 2005
Website: http://ncvs.org/research/neurologic.html

Primary Contacts and Locations

Colorado

• Heather Gustafson, MA, CCC-SLP
  National Center for Voice and Speech at The Denver Center for the Performing Art
  pdresearch@dcpa.org
  Phone: 303-893-6025
  DCPA Tramway Building
  1101 13th Street
  Denver, CO 80204
  USA