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Efficacy of Voice Treatment for Parkinson's Disease

Primary Purpose

Parkinson's Disease, Dysphagia, Dysarthria

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Voice/Respiration Treatment
Speech/Articulation Treatment
Sponsored by
University of Colorado, Boulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Swallowing difficulties, speech, voice

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Center for Voice and Speech-Denver; An Affiliate of the unniversity of Colorado
  • University of Texas HSC San Antonio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Voice/Respiratory Treatment

Articulation Treatment

Subjects with PD in a no treatment group

Healthy Control Subjects

Arm Description

4 Days a week for 4 weeks with focus on high intensity voice exercises

4 days a week for 4 weeks with focus on high intensity articulation tasks

Subjects do not receive therapy during experimental phases, and will be offered therapy at the end of the study enrollment period.

Subjects are without Parkinson disease and will not receive therapy.

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
July 20, 2005
Last Updated
July 27, 2018
Sponsor
University of Colorado, Boulder
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00123084
Brief Title
Efficacy of Voice Treatment for Parkinson's Disease
Official Title
Efficacy of Voice Treatment for Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
September 30, 2012 (Actual)
Study Completion Date
September 30, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Boulder
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Dysphagia, Dysarthria
Keywords
Parkinson's disease, Swallowing difficulties, speech, voice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
620 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Voice/Respiratory Treatment
Arm Type
Experimental
Arm Description
4 Days a week for 4 weeks with focus on high intensity voice exercises
Arm Title
Articulation Treatment
Arm Type
Experimental
Arm Description
4 days a week for 4 weeks with focus on high intensity articulation tasks
Arm Title
Subjects with PD in a no treatment group
Arm Type
No Intervention
Arm Description
Subjects do not receive therapy during experimental phases, and will be offered therapy at the end of the study enrollment period.
Arm Title
Healthy Control Subjects
Arm Type
No Intervention
Arm Description
Subjects are without Parkinson disease and will not receive therapy.
Intervention Type
Behavioral
Intervention Name(s)
Voice/Respiration Treatment
Other Intervention Name(s)
LSVT LOUD
Intervention Description
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort exercises focusing on increased loudness and good voice quality.
Intervention Type
Behavioral
Intervention Name(s)
Speech/Articulation Treatment
Other Intervention Name(s)
LSVT ARTIC
Intervention Description
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorraine Ramig, PhD, CCC-SLP
Organizational Affiliation
Professor, University of Colorado-Boulder; Senior Scientist, National Center for Voice and Speech-Denver; Adjunct Professor, Columbia University-NYC
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Voice and Speech-Denver; An Affiliate of the unniversity of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
University of Texas HSC San Antonio
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32639484
Citation
Levy ES, Moya-Gale G, Chang YHM, Freeman K, Forrest K, Brin MF, Ramig LA. The effects of intensive speech treatment on intelligibility in Parkinson's disease: A randomised controlled trial. EClinicalMedicine. 2020 Jun 28;24:100429. doi: 10.1016/j.eclinm.2020.100429. eCollection 2020 Jul.
Results Reference
derived

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Efficacy of Voice Treatment for Parkinson's Disease

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