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Identification and Comprehension of Focused Stress in a Sentence Among Adults Who Suffered Traumatic Brain Injury

Primary Purpose

Focused Stress

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
language and cognitive tests
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Focused Stress

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

adult who suffered traumatic brain injury

control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2015
Last Updated
December 21, 2015
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02499133
Brief Title
Identification and Comprehension of Focused Stress in a Sentence Among Adults Who Suffered Traumatic Brain Injury
Official Title
Identification and Comprehension of Focused Stress in a Sentence Among Adults Who Suffered Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focused Stress

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
adult who suffered traumatic brain injury
Arm Type
Other
Arm Title
control group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
language and cognitive tests
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Hebrew Focused Stress Test (HFST)
Description
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.
Time Frame
15 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harold Weingarden, MD
Phone
97235305979
Email
Harold.Weingarden@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hadar Friedman
Phone
97235305979
Email
hadarfriedman97@gmail.com
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harold Weingarden, MD
Email
Harold.Weingarden@sheba.health.gov.il

12. IPD Sharing Statement

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Identification and Comprehension of Focused Stress in a Sentence Among Adults Who Suffered Traumatic Brain Injury

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