Traumatic Brain InjuryNCT01266356
A TMU/NIH Integrated Research Project Translation of Basic Research to Clinical Diagnosis and Treatment of Mild Traumatic Brain Injury (mTBI)
An observational study of Traumatic Brain Injury, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
This integrated research project is cooperated by an fully-experienced team of Taipei Medical University and National Institutes of Health. We hope that we can find out the disease of balance, anxiety and sick headaches through the translation of basic research to clinical diagnosis and treatment of Mild Traumatic… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2009to Aug 2012
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Brain Injury Patients
Who may be able to join
- willing to accept this research
- age above 17 years old
- brain injury patients who are in Glasgow Coma Scale(GCS) between 13 to 15
Who cannot join
- age under 16 years old
- serious brain injury patients
- pregnant women
- people who have accepted ears surgery once
- uremia
- Liver Cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
This integrated research project is cooperated by an fully-experienced team of Taipei Medical University and National Institutes of Health. We hope that we can find out the disease of balance, anxiety and sick headaches through the translation of basic research to clinical diagnosis and treatment of Mild Traumatic Brain Injury (mTBI).
- Conditions
- Traumatic Brain Injury
- Keywords
- Minor Traumatic Brain Injury, Translation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Not described | |
| Control Group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startAug 2009
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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-control
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wen-Ta Chiu, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266356
- Sponsor's protocol ID
- 99019
- Status last verified
- Dec 2010
- First submitted
- 22 Dec 2010
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A TMU/NIH Integrated Research Project Translation of Basic Research to Clinical Diagnosis and Treatment of Mild Traumatic Brain Injury (mTBI)
- ClinicalTrials.gov ID
- NCT01266356
- Acronym / sponsor ID
- 99019
- Conditions
- Traumatic Brain Injury
- Keywords
- Minor Traumatic Brain Injury, Translation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Study completion
- Aug 2012 (estimated)
- First posted
- 24 Dec 2010 (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 integrated research project is cooperated by an fully-experienced team of Taipei Medical University and National Institutes of Health. We hope that we can find out the disease of balance, anxiety and sick headaches through the translation of basic research to clinical diagnosis and treatment of Mild Traumatic Brain Injury (mTBI).
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Brain Injury Patients
Key inclusion criteria (3 listed)
- willing to accept this research
- age above 17 years old
- brain injury patients who are in Glasgow Coma Scale(GCS) between 13 to 15
Key exclusion criteria (6 listed)
- age under 16 years old
- serious brain injury patients
- pregnant women
- people who have accepted ears surgery once
- uremia
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
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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.
Wen-Ta Chiu principal investigator
Taipei Medical University
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 Traumatic Brain Injury, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 6 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: status not confirmed, as of the sponsor's last update on 24 Dec 2010. 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 Taiwan. 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?
Results are not available in the source record.
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 24 Dec 2010.