Persons With Frontal Lobe Damage With no Specific Language DisorderNCT01696292
Evaluation of Mental Flexibility Through Language Tests in Adolescents With Frontal Brain Damage and in Healthy Children in Ages 8-17
An observational study of Persons With Frontal Lobe Damage With no Specific Language Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This study aims to shed light on the theoretical concept of mental flexibility and its manifestation in adolescents following frontal lobe damage, and to develop a test battery for young Hebrew speakers. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Persons With Frontal Lobe Damage With no Specific Language Disorder
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2004to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: A group of children ages 8-17 with frontal lobe damage, who are treated at the children rehabilitation center at sheba medical center
Who may be able to join
- frontal lobe damage
- at least one year after injury
- native hebrew speaker
Who cannot join
- specific language disorder
- premorbid learning disability
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to shed light on the theoretical concept of mental flexibility and its manifestation in adolescents following frontal lobe damage, and to develop a test battery for young Hebrew speakers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startAug 2004
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persons With Frontal Lobe Damage With no Specific Language DisorderStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696292
- Sponsor's protocol ID
- SHEBA-04-3435-JL-CTIL
- Status last verified
- Sep 2012
- First submitted
- 27 Sep 2012
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mental Flexibility Through Language Tests in Adolescents With Frontal Brain Damage and in Healthy Children in Ages 8-17
- ClinicalTrials.gov ID
- NCT01696292
- Acronym / sponsor ID
- SHEBA-04-3435-JL-CTIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to shed light on the theoretical concept of mental flexibility and its manifestation in adolescents following frontal lobe damage, and to develop a test battery for young Hebrew speakers.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A group of children ages 8-17 with frontal lobe damage, who are treated at the children rehabilitation center at sheba medical center
Key inclusion criteria (3 listed)
- frontal lobe damage
- at least one year after injury
- native hebrew speaker
Key exclusion criteria (2 listed)
- specific language disorder
- premorbid learning disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persons With Frontal Lobe Damage With no Specific Language Disorder, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2012.