Efficacy of Voice Treatment for Parkinson's Disease
1 other identifier
interventional
620
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2002
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 20, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2012
CompletedJuly 31, 2018
April 1, 2017
10.6 years
July 20, 2005
July 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Voice/Respiratory Treatment
EXPERIMENTAL4 Days a week for 4 weeks with focus on high intensity voice exercises
Articulation Treatment
EXPERIMENTAL4 days a week for 4 weeks with focus on high intensity articulation tasks
Subjects with PD in a no treatment group
NO INTERVENTIONSubjects do not receive therapy during experimental phases, and will be offered therapy at the end of the study enrollment period.
Healthy Control Subjects
NO INTERVENTIONSubjects are without Parkinson disease and will not receive therapy.
Interventions
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort exercises focusing on increased loudness and good voice quality.
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech.
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinson's Disease (IPD)
- None or mild dementia
- None, mild or moderate depression
- Mild, moderate or severe speech, voice, and swallowing disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Center for Voice and Speech-Denver; An Affiliate of the unniversity of Colorado
Denver, Colorado, 80204, United States
University of Texas HSC San Antonio
San Antonio, Texas, United States
Related Publications (1)
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.
PMID: 32639484DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2005
First Posted
July 22, 2005
Study Start
March 1, 2002
Primary Completion
September 30, 2012
Study Completion
September 30, 2012
Last Updated
July 31, 2018
Record last verified: 2017-04