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Pathology in the Brain After mTBI - A Multimodal MRI Study

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ClinicalTrials.gov Identifier: NCT01936792
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : April 21, 2015
Sponsor:
Collaborator:
Regionshospitalet Hammel Neurocenter
Information provided by (Responsible Party):
Erhard Trillingsgaard Næss-Schmidt, University of Aarhus

Brief Summary:

The purpose is to use Diffusion Kurtosis Imaging (DKI), Diffusion Tensor Imaging (DTI) and resting state functional MRI to examine tissue damage in the brains of people who have had a concussion, both acute and 3 months after the accident. A secondary purpose is to examine whether the results of the scans are associated with physical, cognitive and emotional problems after concussion.

It is hypothesized that there will be a change in the diffusion signal measured with DKI in the thalamus (THA) and with DTI in the corpus callosum (CC), in the acute stage and at follow-up of the mTBI subjects compared with the healthy controls. Secondary it is expected that there will be changes in the diffusion signal measured with DKI and DTI in other WM and GM area in both the acute stage and at follow up with mTBI subjects compared with healthy controls. Also rs-fMRI markers are secondary expected to differ in the two groups. Moreover secondarily the MRI markers are tested for correlation with the severity of PCS acutely and at follow up after mTBI.


Condition or disease
Concussion

Show Show detailed description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Pathology in the Brain After mTBI - A Multimodal MRI Study
Study Start Date : August 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Group/Cohort
mild traumatic brain injury
Subjects with mild traumatic brain injury
Controls
Controls with no premorbid health conditions



Primary Outcome Measures :
  1. Change in Mean Kurtosis (MK) in mTBI subjects [ Time Frame: from baseline within 14 days and to follow up 3 month after mTBI ]
    MRI measurement unit


Secondary Outcome Measures :
  1. Difference in MK between mTBI and control subjects [ Time Frame: within 14 days and 3 month after mTBI ]
    MRI measurement unit

  2. Difference in Fractional Anisotropy (FA) between mTBI and control subjects [ Time Frame: within 14 days and 3 month after mTBI ]
    MRI measurement unit

  3. Difference in Mean Diffusivity (MD) between mTBI and control subjects [ Time Frame: within 14 days and 3 month after mTBI ]
    MRI measurement unit

  4. Change of FA in mTBI subjects [ Time Frame: from baseline within 14 days and to follow up 3 month after mTBI ]
    MRI measurement unit

  5. Change of MD in mTBI subjects [ Time Frame: from baseline within 14 days and to follow up 3 month after mTBI ]
    MRI measurement unit

  6. Correlation of clinical symptoms and MRI measurements [ Time Frame: within 14 days and 3 month after mTBI ]
    questionnaire and MRI measurement units

  7. Default mode network [ Time Frame: within 14 days and 3 month after mTBI ]
    measuring the default mode network with resting state -fMRI



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
35 individuals with mTBI and 35 matched healthy controls (age and sex) are examined.
Criteria

Inclusion Criteria:

  • age between 18-40 years
  • negative CT scan
  • A Glasgow Coma Scale (GCS) score that is higher than 13 after 30 minutes
  • one or more of the following characteristics:
  • A period of loss of consciousness for up to 30 minutes
  • A period of amnesia of events immediately before or after the accident within 24 hours before / after the episode
  • Any change in mental state at the time of the accident (eg, dazed, disoriented or confused)
  • Focal neurological deficit, which may or may not be transient

Exclusion Criteria:

  • Psychiatric or neurological diagnosis already
  • The use of drugs, smoking or alcohol eight hours before MRI
  • Alcohol or drug abuse
  • Former mTBI with unconsciousness within the last 2 years
  • Significant other trauma, as the primary symptom
  • MRI contraindications

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): NCT01936792


Locations
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Denmark
Region Hospital Hammel Neurocenter
Hammel, Denmark, 8450
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Hammel Neurocenter
Investigators
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Study Chair: Jørgen F Nielsen, Professor Region Hospital, Hammel Neurocenter, University Clinic, Voldbyvej 15, 8450 Hammel
Additional Information:

Publications:
PALLESEN, H. and TRIER, M., eds, 2006. Inde i varmen eller ude på et sidespor. En redegørrelse om unge med erhvervet hjerneskade og deres særlige problemstillinger. First edn. Denmark: Videnscenter for Hjerneskade.

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Responsible Party: Erhard Trillingsgaard Næss-Schmidt, Pathology in the brain after mTBI - A multimodal MRI study, University of Aarhus
ClinicalTrials.gov Identifier: NCT01936792    
Other Study ID Numbers: 1-10-72-135-13
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: March 2015
Keywords provided by Erhard Trillingsgaard Næss-Schmidt, University of Aarhus:
Concussion
Mild Traumatic Brain Injury
Traumatic Brain Injury