Parkinson DiseasePhase 2ParkinsonicsNCT02753621
Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease
A Phase 2 study testing Group singing and Facilitated Discussion Group in people with Parkinson Disease, run by Johns Hopkins University.
Trial summary
The overall objective of this study is to observe the effect of group Vocal performance training and performance experience on patients' reported symptoms and quality of life. The effectiveness of PD medications varies significantly in different patients depending on their symptoms. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Group singing and Facilitated Discussion Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 31 Dec 2016
- Phase
- Phase 2
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD based on UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for PD (Hughes et al. 1992).
Who cannot join
- Patients unable to consent to the study.
- Patients unable or unwilling to participate in weekly singing classes for 12 weeks, or unwilling to perform in a concert setting.
- Patients with active psychiatric disturbances (agitation, active hallucinations).
About this study
Official title: Parkinsonics: A Controlled Study of Group Singing for Quality of Life and Voice Outcomes in Parkinson Disease
The overall objective of this study is to observe the effect of group Vocal performance training and performance experience on patients' reported symptoms and quality of life. The effectiveness of PD medications varies significantly in different patients depending on their symptoms. By using music-based interventions to improve symptoms that may be inadequately treated by medications, the investigators hope to improve quality of life in PD patients. "Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in Parkinson disease" (PD) is a controlled crossover behavioral intervention study of once weekly choral classes for patients with idiopathic PD (progressing toward a group performance) and once weekly discussion/support group meetings.
- Conditions
- Parkinson Disease
- Being tested
- Group singing, Facilitated Discussion Group
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group singingBehavioural
Weekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks.
Facilitated Discussion GroupBehavioural
Weekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Singing Intervention | Experimental | Twelve weekly group singing classes lasting 60-90 minutes under the direction of a professional choir director and a social worker with a music background. Receives: Behavioral: Group singing |
| Discussion/Support Group Intervention | Active comparator | Twelve weekly 60-90 minute discussion groups led by a facilitator trained in discussion group facilitation; occurring at the same time and in the same location (next door) as experimental intervention (group singing). Receives: Behavioral: Facilitated Discussion Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores
Validated 39-item questionnaire
Measured: Change from baseline scores at 30 weeks
Secondary outcomes (10)
Voice-Related Quality of Life
Validated 10-item questionnaire
Measured: Change from baseline scores at 30 weeks
Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores
Validated Parkinson disease motor assessment scale
Measured: Change from baseline scores at 30 weeks
Montreal Cognitive Assessment
Validated cognitive assessment
Measured: Change from baseline scores at 30 weeks
Geriatric Depression Scale-15
Validated depression self-rating
Measured: Change from baseline scores at 30 weeks
Lorig Self-efficacy scale
5-item self-reported questionnaire
Measured: Change from baseline scores at 30 weeks
Short Form-36
Self-reported questionnaire assessing patients' health based on their physical and mental well-being
Measured: Change from baseline scores at 30 weeks
Sound pressure level (decibels)
Assessed while reading the standardized "Rainbow" passage and describing the cookie theft picture at a 50cm distance from the microphone (using a portable professional decibel meter).
Measured: Change from baseline levels at 30 weeks
Voice jitter
Analysis will be performed using Praat software (Boersma and Weenink, version 5.4.01, http://www.fon.hum.uva.nl/praat/). There will be 3 trials per subject holding sounds A and E for as long as possible on one breath. Sound recordings are made for each trial.
Measured: Change from baseline values at 30 weeks
Voice shimmer
Analysis will be performed using Praat software (Boersma and Weenink, version 5.4.01, http://www.fon.hum.uva.nl/praat/). There will be 3 trials per subject holding sounds A and E for as long as possible on one breath. Sound recordings are made for each trial.
Measured: Change from baseline values at 30 weeks
Harmonic to noise ratio
Analysis will be performed using Praat software (Boersma and Weenink, version 5.4.01, http://www.fon.hum.uva.nl/praat/). There will be 3 trials per subject holding sounds A and E for as long as possible on one breath. Sound recordings are made for each trial.
Measured: Change from baseline values at 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start1 Dec 2015
- Primary completion1 Oct 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Pantelyat, Johns Hopkins University
- Investigators
- Alexander Pantelyat, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753621
- Sponsor's protocol ID
- IRB00065196
- Acronym
- Parkinsonics
- Status last verified
- Feb 2017
- First submitted
- 25 Apr 2016
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinsonics: A Controlled Study of Group Singing for Quality of Life and Voice Outcomes in Parkinson Disease
- ClinicalTrials.gov ID
- NCT02753621
- Acronym / sponsor ID
- Parkinsonics / IRB00065196
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 28 Apr 2016 (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 overall objective of this study is to observe the effect of group Vocal performance training and performance experience on patients' reported symptoms and quality of life. The effectiveness of PD medications varies significantly in different patients depending on their symptoms. By using music-based interventions to improve symptoms that may be inadequately treated by medications, the investigators hope to improve quality of life in PD patients. "Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in Parkinson disease" (PD) is a controlled crossover behavioral intervention study of once weekly choral classes for patients with idiopathic PD (progressing toward a group performance) and once weekly discussion/support group meetings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Singing Intervention | Experimental | Behavioral: Group singingTwelve weekly group singing classes lasting 60-90 minutes under the direction of a professional choir director and a social worker with a music background. |
| Discussion/Support Group Intervention | Active comparator | Behavioral: Facilitated Discussion GroupTwelve weekly 60-90 minute discussion groups led by a facilitator trained in discussion group facilitation; occurring at the same time and in the same location (next door) as experimental intervention (group singing). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of idiopathic PD based on UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for PD (Hughes et al. 1992).
Key exclusion criteria (3 listed)
- Patients unable to consent to the study.
- Patients unable or unwilling to participate in weekly singing classes for 12 weeks, or unwilling to perform in a concert setting.
- Patients with active psychiatric disturbances (agitation, active hallucinations).
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 |
|---|---|---|
| Group singingWeekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks. | Behavioural | Singing Intervention |
| Facilitated Discussion GroupWeekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks. | Behavioural | Discussion/Support Group Intervention |
Primary outcome
Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores
Time frame: Change from baseline scores at 30 weeks
Validated 39-item questionnaire
10 secondary outcomes
Voice-Related Quality of Life
Time frame: Change from baseline scores at 30 weeks
Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores
Time frame: Change from baseline scores at 30 weeks
Montreal Cognitive Assessment
Time frame: Change from baseline scores at 30 weeks
Geriatric Depression Scale-15
Time frame: Change from baseline scores at 30 weeks
Lorig Self-efficacy scale
Time frame: Change from baseline scores at 30 weeks
Short Form-36
Time frame: Change from baseline scores at 30 weeks
Sound pressure level (decibels)
Time frame: Change from baseline levels at 30 weeks
Voice jitter
Time frame: Change from baseline values at 30 weeks
Voice shimmer
Time frame: Change from baseline values at 30 weeks
Harmonic to noise ratio
Time frame: Change from baseline values at 30 weeks
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 1 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Alexander Pantelyat, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group singing and Facilitated Discussion Group in people with Parkinson Disease, run by Johns Hopkins University.
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 1 inclusion and 3 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores (time frame: Change from baseline scores at 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2017.