Tampere Traumatic Head and Brain Injury Study (TheBrainS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teemu Luoto, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01427959
First received: September 1, 2011
Last updated: March 10, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

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

Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427959

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

No publications provided

Responsible Party: Teemu Luoto, Medical Researcher, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01427959     History of Changes
Other Study ID Numbers: R10027
Study First Received: September 1, 2011
Last Updated: March 10, 2014
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014