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Tampere Traumatic Head and Brain Injury Study (TheBrainS)

This study is currently recruiting participants.
Verified October 2016 by Teemu Luoto, Tampere University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01427959
First Posted: September 2, 2011
Last Update Posted: October 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Teemu Luoto, Tampere University Hospital
  Purpose
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.

Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tampere Traumatic Head and Brain Injury Study

Further study details as provided by Teemu Luoto, Tampere University Hospital:

Biospecimen Retention:   Samples With DNA
  1. 10ml whole blood
  2. 10ml EDTA-blood x2

Estimated Enrollment: 100
Study Start Date: November 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Detailed Description:

Aims of the study:

  1. To improve clinical assessment of mTBI in the acute phase
  2. To assemble better knowledge of diffusion tensor imaging as a diagnostic tool in mTBI
  3. To improve neuropsychological evaluation of mTBI Main focus on psychosocial functioning / outcome / correlates E.g. Resilience, PTSD
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community sample consisting of consecutive mild traumatic brain injury patients metting the enrollment criteria.
Criteria

Inclusion Criteria:

  • WHO's mtbi criteria
  • Inhabitant of Pirkanmaa hospital district
  • Age between 18 and 60 years

Exclusion Criteria:

  • Detrimental alcohol use
  • Drug addiction
  • Chronic neurological disease
  • Earlier brain injury
  • Diagnosed psychiatric disease
  • Hearing or sight deficiency
  • Native language other than finnish
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427959


Contacts
Contact: Teemu M. Luoto, M.D. +358505986699 teemu.luoto@pshp.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Teemu M. Luoto, M.D.    +358505986699    teemu.luoto@pshp.fi   
Sponsors and Collaborators
Tampere University Hospital
Investigators
Principal Investigator: Teemu M. Luoto, M.D. Tampere University Hospital
  More Information

Responsible Party: Teemu Luoto, Medical Researcher, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01427959     History of Changes
Other Study ID Numbers: R10027
First Submitted: September 1, 2011
First Posted: September 2, 2011
Last Update Posted: October 19, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System