NCT01776879

Brief 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. Speech intelligibility of first degree relatives will be normal.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

9 months

First QC Date

November 13, 2012

Last Update Submit

January 23, 2013

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    DAY 1

Secondary Outcomes (1)

  • Diadokokinetik (DDK): production time of 10x PATAKA, 7x /P/ and 7x /t/

    DAY 1

Study Arms (3)

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

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced PD patients Early PD patients First degree relatives

You may qualify if:

  • Advanced PD patients
  • Early PD patients
  • First degree relatives

You may not qualify if:

  • Patients with decreased cognitive abilities
  • Patients who participate in speech therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16324824BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Tanya Gurevich, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanya Gurevich, MD

CONTACT

97236973061gurevich@tasmc.health.gov.il

Yael Manor, PhD

CONTACT

97236973061Yaelm@tasmc.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director rnd devision

Study Record Dates

First Submitted

November 13, 2012

First Posted

January 28, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2014

Last Updated

January 28, 2013

Record last verified: 2013-01