Parkinson's DiseaseNCT00123084
Efficacy of Voice Treatment for Parkinson's Disease
A study testing Voice/Respiration Treatment and Speech/Articulation Treatment in people with Parkinson's Disease and Dysphagia, run by University of Colorado, Boulder at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Dysphagia, Dysarthria
- What is being tested?
- Voice/Respiration Treatment and Speech/Articulation Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2002to 30 Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's Disease (IPD)
- None or mild dementia
- None, mild or moderate depression
- Mild, moderate or severe speech, voice, and swallowing disorder
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Center for Voice and Speech-Denver; An Affiliate of the unniversity of Colorado
Denver, Colorado, 80204
University of Texas HSC San Antonio
San Antonio, Texas
About this study
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.
Read the 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
- Being tested
- Voice/Respiration Treatment, Speech/Articulation Treatment
- Keywords
- Parkinson's disease, Swallowing difficulties, speech, voice
- Medical subject headings
- Parkinson Disease, Deglutition Disorders, Dysarthria, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice/Respiration TreatmentBehavioural
Also called LSVT LOUD
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 TreatmentBehavioural
Also called LSVT ARTIC
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech.
| Study group | Role | What they receive |
|---|---|---|
| Voice/Respiratory Treatment | Experimental | 4 Days a week for 4 weeks with focus on high intensity voice exercises Receives: Behavioral: Voice/Respiration Treatment |
| Articulation Treatment | Experimental | 4 days a week for 4 weeks with focus on high intensity articulation tasks Receives: Behavioral: Speech/Articulation Treatment |
| Subjects with PD in a no treatment group | No intervention | Subjects do not receive therapy during experimental phases, and will be offered therapy at the end of the study enrollment period. |
| Healthy Control Subjects | No intervention | Subjects are without Parkinson disease and will not receive therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice intensity; voice fundamental frequency; articulatory acoustics; physiological voice function; speech intelligibility; swallowing function; non-verbal communication behaviors; limb function; neural imaging; neuropsychological functioning
Measured: 8-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startMar 2002
- Primary completion30 Sep 2012
- Study completion30 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Lorraine Ramig, PhD, CCC-SLP, Principal investigator, Professor, University of Colorado-Boulder; Senior Scientist, National Center for Voice and Speech-Denver; Adjunct Professor, Columbia University-NYC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123084
- Sponsor's protocol ID
- R01DC001150
- Other IDs
- R01DC001150
- Status last verified
- Apr 2017
- First submitted
- 20 Jul 2005
- Last updated
- 31 Jul 2018
- Results posted
- No
Publications
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.
PubMed 32639484
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Voice Treatment for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00123084
- Acronym / sponsor ID
- R01DC001150
- Conditions
- Parkinson's Disease, Dysphagia, Dysarthria
- Keywords
- Parkinson's disease, Swallowing difficulties, speech, voice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Mar 2002
- Primary completion
- 30 Sep 2012 (actual)
- Study completion
- 30 Sep 2012 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Voice/Respiratory Treatment | Experimental | Behavioral: Voice/Respiration Treatment4 Days a week for 4 weeks with focus on high intensity voice exercises |
| Articulation Treatment | Experimental | Behavioral: Speech/Articulation Treatment4 days a week for 4 weeks with focus on high intensity articulation tasks |
| Subjects with PD in a no treatment group | No intervention | –Subjects do not receive therapy during experimental phases, and will be offered therapy at the end of the study enrollment period. |
| Healthy Control Subjects | No intervention | –Subjects are without Parkinson disease and will not receive therapy. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic Parkinson's Disease (IPD)
- None or mild dementia
- None, mild or moderate depression
- Mild, moderate or severe speech, voice, and swallowing disorder
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice/Respiration TreatmentAlso: LSVT LOUDTherapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort exercises focusing on increased loudness and good voice quality. | Behavioural | Voice/Respiratory Treatment |
| Speech/Articulation TreatmentAlso: LSVT ARTICTherapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech. | Behavioural | Articulation Treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 32639484Levy 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.
- 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 SpeechLink provided by the sponsor.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorraine Ramig, PhD, CCC-SLP principal investigator
Professor, University of Colorado-Boulder; Senior Scientist, National Center for Voice and Speech-Denver; Adjunct Professor, Columbia University-NYC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice/Respiration Treatment and Speech/Articulation Treatment in people with Parkinson's Disease and Dysphagia, run by University of Colorado, Boulder at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.