Tampere Traumatic Head and Brain Injury Study (TheBrainS)

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. Read our disclaimer for details. Identifier: NCT01427959
Recruitment Status : Active, not recruiting
First Posted : September 2, 2011
Last Update Posted : November 28, 2017
Information provided by (Responsible Party):
Teemu Luoto, Tampere University Hospital

Brief 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. The study is conducted in Tampere University Hospital's emergency department between the 1st of August 2010 and 31st of July 2013.

Condition or disease
Traumatic Brain Injury

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

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tampere Traumatic Head and Brain Injury Study
Study Start Date : November 2010
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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.

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

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 identifier (NCT number): NCT01427959

Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
Principal Investigator: Teemu M. Luoto, M.D. Tampere University Hospital

Responsible Party: Teemu Luoto, Medical Researcher, Tampere University Hospital Identifier: NCT01427959     History of Changes
Other Study ID Numbers: R10027
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

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