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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01776879
Other study ID # TASMC-12-TG-0556-CTIL
Secondary ID 0556-12
Status Not yet recruiting
Phase N/A
First received November 13, 2012
Last updated January 23, 2013
Start date February 2013
Est. completion date November 2014

Study information

Verified date January 2013
Source Tel-Aviv Sourasky Medical Center
Contact Tanya Gurevich, MD
Phone 97236973061
Email gurevich@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 2014
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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
DAY 1 No
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