Cerebral Microstructural Changes Following Mild Traumatic Brain Injury

NCT02331901 | Completed DMC

• 1 other identifier: mtbi-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study examine the possible microstructural changes in the middle brain after mTBI using diffusion MRI

Conditions

Brain Concussion

Outcome Measures

Primary Outcomes (1)

• Diffusion kurtosis Imaging (DKI)

  MRI measurement unit

  2-5 month after mTBI

Secondary Outcomes (1)

• Diffusion Tensor Imaging (DTI)

  2-5 month after mTBI

Other Outcomes (2)

• Symptoms

  2-5 month after mTBI

• Cognitive performance

  2-5 month after mTBI

Study Arms (2)

MTBI SYMP

Mild Traumatic Brain Injury subjects with symptoms

MTBI NO SYMP

Mild Traumatic Brain Injury subjects without symptoms

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mild traumatic brain injury subjects with and without symptoms 3-4 months after trauma

You may qualify if:

• Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri within the last 2-5 months. The criteria are based recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas.
• Age 18 to 30 years at the time of the head trauma.
• Able to understand, speak and read Danish.
• Patients with symptoms at least three items on the Rivermead Post Concussion Symptoms Questionnaire (RPQ) rated as moderate or severe problem. PCS have to be subjectively rated as causing substantial impairment in daily life. Patients with out symptoms (controls) having no problems on the RPQ.

You may not qualify if:

• \. Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating neurological disease or brain damage.
• Previous concussion leading to persistent PCS within the last two years.
• Severe misuse of alcohol, prescription drugs and / or illegal drugs.
• Psychiatric morbidity or severe neurological disease that impedes participation in the treatment, i.e. Bipolar Disorder, autism, psychotic disorder (life time), multiple sclerosis etc..
• Suitable for MRI examination

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Region Hospital Hammel Neurocenter

Hammel, 8450, Denmark

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Erhard T Næss-Schmidt, PhD fellow

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 6, 2015
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)