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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776879
First Posted: January 28, 2013
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
  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 Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Diadokokinetik (DDK): production time of 10x PATAKA, 7x /P/ and 7x /t/ [ Time Frame: DAY 1 ]

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Amir, O., Ashkenazi, O., Leibovitzh, T., Michael, O., Tavor, Y., & Wolf, M. (2006). Applying the Voice Handicap Index (VHI) to Dysphonic and Nondysphonic Hebrew Speakers. Journal of Voice, 318-324. Giladi, N., Treves, T. A., Paleacu, D., Shabtai, H., Orlov, Y., Kandinov, B., Simon, E. S., & Korczyn, A. D. (2000). The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53:695-699 Sapir, S., Raming, L., & Fox, C. (2008) speech and swallowing disorder In Parkinson disease. Speech therapy and rehabilitation. 205-210. Wolters, E. Ch. (2009). Non-motor extranigral signs and symptoms in Parkinson's disease. Parkinsonism and Related Disorders , 6-12. Manor, Y. Giladi, N. Cohen, A. Fliss, D. Cohen. Y. (2007) Validation of a swallowing disturbance questionnaire for detecting dysphagia in patients with Parkinson's disease. Movement Disorders.

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 ( Other Identifier: TEL AVIV MEDICAL CENTER )
First Submitted: November 13, 2012
First Posted: January 28, 2013
Last Update Posted: January 28, 2013
Last Verified: January 2013

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