Efficacy of Voice Treatment for Parkinson's Disease

NCT ID: NCT00123084

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2012-09-30

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

Conditions

Parkinson's Disease; Dysphagia; Dysarthria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Voice/Respiratory Treatment

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

Group Type: EXPERIMENTAL

Voice/Respiration Treatment

Intervention Type: BEHAVIORAL

Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort exercises focusing on increased loudness and good voice quality.

Articulation Treatment

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

Group Type: EXPERIMENTAL

Speech/Articulation Treatment

Intervention Type: BEHAVIORAL

Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech.

Subjects with PD in a no treatment group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Control Subjects

Subjects are without Parkinson disease and will not receive therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

LSVT LOUD; LSVT ARTIC

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of Colorado, Boulder

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorraine Ramig, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

Professor, University of Colorado-Boulder; Senior Scientist, National Center for Voice and Speech-Denver; Adjunct Professor, Columbia University-NYC

Locations

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, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32639484 (View on PubMed)

Other Identifiers

R01DC001150

Identifier Type: NIH

Identifier Source: secondary_id

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R01DC001150

Identifier Type: NIH

Identifier Source: org_study_id

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