Traumatic Brain InjuryTheBrainSNCT01427959
Tampere Traumatic Head and Brain Injury Study
An observational study of Traumatic Brain Injury, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Tampere Traumatic head and brain injury study is a prospective study aiming to explore neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 115 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2010to Feb 2021
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample consisting of consecutive mild traumatic brain injury patients metting the enrollment criteria.
Who may be able to join
- WHO's mtbi criteria
- Inhabitant of Pirkanmaa hospital district
- Age between 18 and 60 years
Who cannot join
- Detrimental alcohol use
- Drug addiction
- Chronic neurological disease
- Earlier brain injury
- Diagnosed psychiatric disease
- Hearing or sight deficiency
- Native language other than finnish
Trial locations and contacts
1 site in 1 country.
About this study
Tampere Traumatic head and brain injury study is a prospective study aiming to explore neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi. The study is conducted in Tampere University Hospital's emergency department between the 1st of August 2010 and 31st of July 2013.
Read the detailed description
Aims of the study:
- To improve clinical assessment of mTBI in the acute phase
- To assemble better knowledge of diffusion tensor imaging as a diagnostic tool in mTBI
- To improve neuropsychological evaluation of mTBI Main focus on psychosocial functioning / outcome / correlates E.g. Resilience, PTSD
- Conditions
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2021
- Study completionFeb 2021
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.
- More trials run by Tampere University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teemu Luoto, Tampere University Hospital
- Investigators
- Teemu M. Luoto, M.D., Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427959
- Sponsor's protocol ID
- R10027
- Acronym
- TheBrainS
- Status last verified
- Oct 2021
- First submitted
- 1 Sep 2011
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tampere Traumatic Head and Brain Injury Study
- ClinicalTrials.gov ID
- NCT01427959
- Acronym / sponsor ID
- TheBrainS / R10027
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 2 Sep 2011 (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.
Tampere Traumatic head and brain injury study is a prospective study aiming to explore neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi. The study is conducted in Tampere University Hospital's emergency department between the 1st of August 2010 and 31st of July 2013.
Detailed description
Aims of the study:
- To improve clinical assessment of mTBI in the acute phase
- To assemble better knowledge of diffusion tensor imaging as a diagnostic tool in mTBI
- To improve neuropsychological evaluation of mTBI Main focus on psychosocial functioning / outcome / correlates E.g. Resilience, PTSD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample consisting of consecutive mild traumatic brain injury patients metting the enrollment criteria.
Key inclusion criteria (3 listed)
- WHO's mtbi criteria
- Inhabitant of Pirkanmaa hospital district
- Age between 18 and 60 years
Key exclusion criteria (7 listed)
- Detrimental alcohol use
- Drug addiction
- Chronic neurological disease
- Earlier brain injury
- Diagnosed psychiatric disease
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 6 Oct 2021.
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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.
Teemu M. Luoto, M.D. principal investigator
Tampere University Hospital
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 Tampere University Hospital at 1 site in Finland.
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 7 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 6 Oct 2021. 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 Finland. 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 6 Oct 2021.