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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02499133
Other study ID # SHEBA-14-1031-HW-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received January 8, 2015
Last updated December 21, 2015
Start date September 2015
Est. completion date September 2016

Study information

Verified date July 2015
Source Sheba Medical Center
Contact Harold Weingarden, MD
Phone 97235305979
Email Harold.Weingarden@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

Researches that focus on the perception of prosodic elements among adult who suffered traumatic brain injury (TBI), focus on their ability to decipher intonation in order to understand an additional meaning of a sentence. According to these researches, adults who suffer from TBI, with no signs of Aphasia, have difficulty perceiving and deciphering intonation (Marquardt et al., 2001; Angeleri et al., 2008). The current research asks to broaden the knowledge in this domain by examining the ability of adults with TBI to understand an additional prosodic element - focused stress.

The ability to identify and understand focused stress in a sentence requires different abilities. First, a psychoacoustic ability in order to detect the stressed word. Second, an ability to understand the lexical grammatical meaning of the word as it negates other possible meanings (for example, in the sentence "I'm eating a red apple" the stressed word negated the option of a different color). Third, an understanding of the stressed word as it creates a different pragmatic/social meaning (for example, in the sentence "mom, I asked for red, yellow and green candy" the role of the stressed word is to mark the candy that the addressee didn't get).

The aim of the study is to assess the ability of adults who had experienced TBI to grasp and understand the meaning of focused stress in the different contexts that were described above. An additional aim is to examine if differences in speech and cognitive abilities can describe some of the variation in the results.

Thirty adults between the ages of 18-50 years will take part in this study, fifteen adults who had experienced moderate to severe TBI (0.5-3 years post injury) and fifteen healthy adults. Each participant with TBI will be matched to a healthy adult by gender, age, education and social-economic status. All of the participants will be Hebrew native speakers, with no learning disability, no neurological injury, proper speech abilities and no hearing impairment.

The participants will undergo seven different tests in three different meetings (60 minute each), in a quiet room at Sheba - Academic Medical Center Hospital. The tests will include different cognitive and language examinations. The main test of the study will be The Hebrew Focused Stress Test (HFST). The HFST includes three subtests. The first subtest requires identification of the stressed word in a sentence based on psychoacoustic abilities alone. The second and the third subtests require understanding the meaning of focused stress in different contexts - lexical grammatical and pragmatic/social. The test includes forty eight recorded sentences. In each sentence one word is stressed. The participants will be asked to listen to the recordings and answer a closed question regarding the stressed word.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Severity between moderate - severe as measured by the Glascow Coma Scale and time of PTA.

- Hebrew native speakers.

- between the ages of 18-50 years old.

- with no history of head trauma.

- with no history of use of addictive substance.

- with no history of psychiatric disorder.

- with no history of language disorder or language learning disability.

- with no degenerative cognition.

- are not suffering from aphasia.

- with a vision good enough to perform the tests of the study.

- with no hearing impairment.

- with a reading ability that is good enough to perform the test of the study.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
language and cognitive tests
The participants will undergo seven different. The tests will include different cognitive and language examinations. The main test of the study will be The Hebrew Focused Stress Test (HFST). The HFST includes three subtests. The first subtest requires identification of the stressed word in a sentence based on psychoacoustic abilities alone. The second and the third subtests require understanding the meaning of focused stress in different contexts - lexical grammatical and pragmatic/social. The test includes forty eight recorded sentences. In each sentence one word is stressed. The participants will be asked to listen to the recordings and answer a closed question regarding the stressed word.

Locations

Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Hebrew Focused Stress Test (HFST) The HFST includes three subtests. The first subtest requires identification of the stressed word in a sentence based on psychoacoustic abilities alone. The second and the third subtests require understanding the meaning of focused stress in different contexts - lexical grammatical and pragmatic/social. The test includes forty eight recorded sentences. In each sentence one word is stressed. The participants will be asked to listen to the recordings and answer a closed question regarding the stressed word. 15 min No