Parkinson's DiseaseNCT01776879
Speech Intelligibility of Patients With P D Compared to First Degree Relatives of P D Patients
An observational study of Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center.
Trial summary
This study will examine speech intelligibility of early parkinson's disease (PD) patients, early PD patients and first degree relatives. The investigators hypothesis that advanced PD patients will present decreased speech intelligibility more than early PD patients. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Nov 2014
- Phase
- Observational
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Advanced PD patients Early PD patients First degree relatives
Who may be able to join
- Advanced PD patients
- Early PD patients
- First degree relatives
Who cannot join
- Patients with decreased cognitive abilities
- Patients who participate in speech therapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Speech Intelligibility of Patients With Parkinsons Disease at Different Stages of the Disease Compared to First Degree Relatives of Parkinson's Disease Patients
This study will examine speech intelligibility of early parkinson's disease (PD) patients, early PD patients and first degree relatives. The investigators hypothesis that advanced PD patients will present decreased speech intelligibility more than early PD patients. Speech intelligibility of first degree relatives will be normal.
Read the detailed description
in order to achieve the study's goals objective and subjective research tools will be used.
Objective tools include measuring phonation time, diadokokinetic movements of the oral structures and acoustic analysis .
Subjective tools include self reported questionnaires.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| early & advanced PD 1st degree relatives | no intervention is performed in the study | |
| recording speech and voice | no intervention(s) will be administered | |
| speech intelligibility | no intervention(s) will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum phonation time
maximum phonation time will be measured after taking few measurements of sentence reading.It is an observational study that aim to collect data during DAY 1 only! day 1 for outcome measure time frames There are not pre/post measurements
Measured: DAY 1
Secondary outcomes (1)
Diadokokinetik (DDK): production time of 10x PATAKA, 7x /P/ and 7x /t/
production time of 10x PATAKA, 7x /P/ and 7x /t/ will be measured during the examination.
It is an observational study that aim to collect data during DAY 1 only! DAY 1 for outcome measure time frames There are not pre/post measurements
Measured: DAY 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2014 (estimated)
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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
- Investigators
- Tanya Gurevich, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776879
- Sponsor's protocol ID
- TASMC-12-TG-0556-CTIL
- Other IDs
- 0556-12
- Status last verified
- Jan 2013
- First submitted
- 13 Nov 2012
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Amir O, Ashkenazi O, Leibovitzh T, Michael O, Tavor Y, Wolf M. Applying the Voice Handicap Index (VHI) to dysphonic and nondysphonic Hebrew speakers. J Voice. 2006 Jun;20(2):318-24. doi: 10.1016/j.jvoice.2005.08.006. Epub 2005 Dec 1.
PubMed 16324824
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Intelligibility of Patients With Parkinsons Disease at Different Stages of the Disease Compared to First Degree Relatives of Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT01776879
- Acronym / sponsor ID
- TASMC-12-TG-0556-CTIL
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 28 Jan 2013 (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.
This study will examine speech intelligibility of early parkinson's disease (PD) patients, early PD patients and first degree relatives. The investigators hypothesis that advanced PD patients will present decreased speech intelligibility more than early PD patients. Speech intelligibility of first degree relatives will be normal.
Detailed description
in order to achieve the study's goals objective and subjective research tools will be used.
Objective tools include measuring phonation time, diadokokinetic movements of the oral structures and acoustic analysis .
Subjective tools include self reported questionnaires.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| early & advanced PD 1st degree relatives | – | –no intervention is performed in the study |
| recording speech and voice | – | –no intervention(s) will be administered |
| speech intelligibility | – | –no intervention(s) will be administered |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced PD patients Early PD patients First degree relatives
Key inclusion criteria (3 listed)
- Advanced PD patients
- Early PD patients
- First degree relatives
Key exclusion criteria (2 listed)
- Patients with decreased cognitive abilities
- Patients who participate in speech therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum phonation time
Time frame: DAY 1
maximum phonation time will be measured after taking few measurements of sentence reading.It is an observational study that aim to collect data during DAY 1 only! day 1 for outcome measure time frames There are not pre/post measurements
1 secondary outcome
Diadokokinetik (DDK): production time of 10x PATAKA, 7x /P/ and 7x /t/
Time frame: DAY 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Background: PubMed 16324824Amir O, Ashkenazi O, Leibovitzh T, Michael O, Tavor Y, Wolf M. Applying the Voice Handicap Index (VHI) to dysphonic and nondysphonic Hebrew speakers. J Voice. 2006 Jun;20(2):318-24. doi: 10.1016/j.jvoice.2005.08.006. Epub 2005 Dec 1.
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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.
Tanya Gurevich, MD principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jan 2013. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanya Gurevich, MD (97236973061, gurevich@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum phonation time (time frame: DAY 1). 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 NCT01776879, 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 28 Jan 2013.