Parkinson's DiseaseNCT01512732
Validation of the Hebrew Version of the Montreal Affective Voices.
An observational study of Parkinson's Disease and Depression, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Today, no non-verbal auditory stimuli that assess mental processing are available in Israel. The goal of this study is to make available a validated set of auditory stimuli in Israel. We created a computerized Hebrew version of the Montreal Affective Voices (MAV). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Depression
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2012to not given
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy group, Parkinson's disease patients, Major depressive disorder patients.
Who may be able to join
- Healthy group
- Parkinson's disease
- Major depressive disorder
- All participants will be competent and willing to give written informed consent. Patients over 65 and/or suspected to have a cognitive decline will be tested by the Mini-mental test and will be included in the study only if the score is above 26.
Who cannot join
- Non-competent or unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization,
Jerusalem
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
Renana Eitan, MD
About this study
Today, no non-verbal auditory stimuli that assess mental processing are available in Israel. The goal of this study is to make available a validated set of auditory stimuli in Israel. We created a computerized Hebrew version of the Montreal Affective Voices (MAV). The MAV is a novel tool for assessing mental processing. The MAV consists of 90 nonverbal affect bursts corresponding to nine different emotions (such as anger, fear, happiness etc.) recorded by ten different actors. The uniqueness of these affective bursts is that they do not contain verbal context, but rather express affective moods using the vowel /a/ (as in "apple"). In this study, the investigators will verify the new Hebrew version of MAV in healthy control groups. Next, the investigators will compare the mental processing ability in young vs. old population, using the MAV test. In addition, the investigators will assess mental processing in two pathologic study groups (Parkinson's disease, major depressive disorder) using the MAV test. The investigators intend to use the MAV tool in future research in Parkinson's disease and depression.
- Conditions
- Parkinson's Disease, Depression
- Medical subject headings
- Parkinson Disease, Depression
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 |
|---|---|---|
| healthy control group | Young (20-49) and Older (50-70) healthy group (n=60) | |
| Parkinson's disease patients | (n=30). | |
| Major depressive disorder patients | (n=30). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verifying the results achieved by Belin et al (2008) when using the Hebrew version of the MAV bursts in healthy control groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512732
- Sponsor's protocol ID
- HebVerMAV-HMO-CTIL
- Status last verified
- Jan 2012
- First submitted
- 15 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Hebrew Version of the Montreal Affective Voices.
- ClinicalTrials.gov ID
- NCT01512732
- Acronym / sponsor ID
- HebVerMAV-HMO-CTIL
- Conditions
- Parkinson's Disease, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2012
- First posted
- 19 Jan 2012 (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.
Today, no non-verbal auditory stimuli that assess mental processing are available in Israel. The goal of this study is to make available a validated set of auditory stimuli in Israel. We created a computerized Hebrew version of the Montreal Affective Voices (MAV). The MAV is a novel tool for assessing mental processing. The MAV consists of 90 nonverbal affect bursts corresponding to nine different emotions (such as anger, fear, happiness etc.) recorded by ten different actors. The uniqueness of these affective bursts is that they do not contain verbal context, but rather express affective moods using the vowel /a/ (as in "apple"). In this study, the investigators will verify the new Hebrew version of MAV in healthy control groups. Next, the investigators will compare the mental processing ability in young vs. old population, using the MAV test. In addition, the investigators will assess mental processing in two pathologic study groups (Parkinson's disease, major depressive disorder) using the MAV test. The investigators intend to use the MAV tool in future research in Parkinson's disease and depression.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy control group | – | –Young (20-49) and Older (50-70) healthy group (n=60) |
| Parkinson's disease patients | – | –(n=30). |
| Major depressive disorder patients | – | –(n=30). |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy group, Parkinson's disease patients, Major depressive disorder patients.
Key inclusion criteria (4 listed)
- Healthy group
- Parkinson's disease
- Major depressive disorder
- All participants will be competent and willing to give written informed consent. Patients over 65 and/or suspected to have a cognitive decline will be tested by the Mini-mental test and will be included in the study only if the score is above 26.
Key exclusion criteria (1 listed)
- Non-competent or unable to give written informed consent
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
Verifying the results achieved by Belin et al (2008) when using the Hebrew version of the MAV bursts in healthy control groups.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Depression, run by Hadassah Medical Organization at 1 site in Israel.
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 1 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 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renana Eitan, Dr (972-050-4048165, renanaeitan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verifying the results achieved by Belin et al (2008) when using the Hebrew version of the MAV bursts in healthy control groups. (time frame: 12 months). 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 24 Jan 2012.