Speech Intelligibility of Patients With P D Compared to First Degree Relatives of P D Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01776879
First received: November 13, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Maximum phonation time [ Time Frame: DAY 1 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Diadokokinetik (DDK): production time of 10x PATAKA, 7x /P/ and 7x /t/ [ Time Frame: DAY 1 ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Advanced PD patients Early PD patients First degree relatives

Criteria

Inclusion Criteria:A

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

Exclusion Criteria:

  • Patients with decreased cognitive abilities
  • Patients who participate in speech therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776879

Contacts
Contact: Tanya Gurevich, MD 97236973061 gurevich@tasmc.health.gov.il
Contact: Yael Manor, PhD 97236973061 Yaelm@tasmc.health.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Tanya Gurevich, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Michal Roll PhD,MBA, director rnd devision, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01776879     History of Changes
Other Study ID Numbers: TASMC-12-TG-0556-CTIL, 0556-12
Study First Received: November 13, 2012
Last Updated: January 23, 2013
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 16, 2014