NCT01936792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 21, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

August 21, 2013

Last Update Submit

April 17, 2015

Conditions

Concussion

Keywords

ConcussionMild Traumatic Brain InjuryTraumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Kurtosis (MK) in mTBI subjects

    MRI measurement unit

    from baseline within 14 days and to follow up 3 month after mTBI

Secondary Outcomes (7)

  • Difference in MK between mTBI and control subjects

    within 14 days and 3 month after mTBI

  • Difference in Fractional Anisotropy (FA) between mTBI and control subjects

    within 14 days and 3 month after mTBI

  • Difference in Mean Diffusivity (MD) between mTBI and control subjects

    within 14 days and 3 month after mTBI

  • Change of FA in mTBI subjects

    from baseline within 14 days and to follow up 3 month after mTBI

  • Change of MD in mTBI subjects

    from baseline within 14 days and to follow up 3 month after mTBI

  • +2 more secondary outcomes

Study Arms (2)

mild traumatic brain injury

Subjects with mild traumatic brain injury

Controls

Controls with no premorbid health conditions

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

35 individuals with mTBI and 35 matched healthy controls (age and sex) are examined.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Hospital Hammel Neurocenter

Hammel, 8450, Denmark

Location

Related Publications (14)

  • Aoki Y, Inokuchi R, Gunshin M, Yahagi N, Suwa H. Diffusion tensor imaging studies of mild traumatic brain injury: a meta-analysis. J Neurol Neurosurg Psychiatry. 2012 Sep;83(9):870-6. doi: 10.1136/jnnp-2012-302742. Epub 2012 Jul 14.

    PMID: 22797288BACKGROUND

  • Beauchamp MH, Ditchfield M, Babl FE, Kean M, Catroppa C, Yeates KO, Anderson V. Detecting traumatic brain lesions in children: CT versus MRI versus susceptibility weighted imaging (SWI). J Neurotrauma. 2011 Jun;28(6):915-27. doi: 10.1089/neu.2010.1712. Epub 2011 Jun 9.

    PMID: 21501069BACKGROUND

  • Grossman EJ, Ge Y, Jensen JH, Babb JS, Miles L, Reaume J, Silver JM, Grossman RI, Inglese M. Thalamus and cognitive impairment in mild traumatic brain injury: a diffusional kurtosis imaging study. J Neurotrauma. 2012 Sep;29(13):2318-27. doi: 10.1089/neu.2011.1763. Epub 2011 Sep 15.

    PMID: 21639753BACKGROUND

  • Grossman EJ, Jensen JH, Babb JS, Chen Q, Tabesh A, Fieremans E, Xia D, Inglese M, Grossman RI. Cognitive impairment in mild traumatic brain injury: a longitudinal diffusional kurtosis and perfusion imaging study. AJNR Am J Neuroradiol. 2013 May;34(5):951-7, S1-3. doi: 10.3174/ajnr.A3358. Epub 2012 Nov 22.

    PMID: 23179649BACKGROUND

  • Iverson GL. Outcome from mild traumatic brain injury. Curr Opin Psychiatry. 2005 May;18(3):301-17. doi: 10.1097/01.yco.0000165601.29047.ae.

    PMID: 16639155BACKGROUND

  • Jeter CB, Hergenroeder GW, Hylin MJ, Redell JB, Moore AN, Dash PK. Biomarkers for the diagnosis and prognosis of mild traumatic brain injury/concussion. J Neurotrauma. 2013 Apr 15;30(8):657-70. doi: 10.1089/neu.2012.2439.

    PMID: 23062081BACKGROUND

  • Lovden M, Bodammer NC, Kuhn S, Kaufmann J, Schutze H, Tempelmann C, Heinze HJ, Duzel E, Schmiedek F, Lindenberger U. Experience-dependent plasticity of white-matter microstructure extends into old age. Neuropsychologia. 2010 Nov;48(13):3878-83. doi: 10.1016/j.neuropsychologia.2010.08.026. Epub 2010 Sep 15.

    PMID: 20816877BACKGROUND

  • Mayer AR, Mannell MV, Ling J, Gasparovic C, Yeo RA. Functional connectivity in mild traumatic brain injury. Hum Brain Mapp. 2011 Nov;32(11):1825-35. doi: 10.1002/hbm.21151. Epub 2011 Jan 21.

    PMID: 21259381BACKGROUND

  • McDonald BC, Saykin AJ, McAllister TW. Functional MRI of mild traumatic brain injury (mTBI): progress and perspectives from the first decade of studies. Brain Imaging Behav. 2012 Jun;6(2):193-207. doi: 10.1007/s11682-012-9173-4.

    PMID: 22618832BACKGROUND

  • Messe A, Caplain S, Paradot G, Garrigue D, Mineo JF, Soto Ares G, Ducreux D, Vignaud F, Rozec G, Desal H, Pelegrini-Issac M, Montreuil M, Benali H, Lehericy S. Diffusion tensor imaging and white matter lesions at the subacute stage in mild traumatic brain injury with persistent neurobehavioral impairment. Hum Brain Mapp. 2011 Jun;32(6):999-1011. doi: 10.1002/hbm.21092. Epub 2010 Jul 28.

    PMID: 20669166BACKGROUND

  • 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.

    BACKGROUND

  • Toledo E, Lebel A, Becerra L, Minster A, Linnman C, Maleki N, Dodick DW, Borsook D. The young brain and concussion: imaging as a biomarker for diagnosis and prognosis. Neurosci Biobehav Rev. 2012 Jul;36(6):1510-31. doi: 10.1016/j.neubiorev.2012.03.007. Epub 2012 Mar 28.

    PMID: 22476089BACKGROUND

  • Vagnozzi R, Signoretti S, Cristofori L, Alessandrini F, Floris R, Isgro E, Ria A, Marziali S, Zoccatelli G, Tavazzi B, Del Bolgia F, Sorge R, Broglio SP, McIntosh TK, Lazzarino G. Assessment of metabolic brain damage and recovery following mild traumatic brain injury: a multicentre, proton magnetic resonance spectroscopic study in concussed patients. Brain. 2010 Nov;133(11):3232-42. doi: 10.1093/brain/awq200. Epub 2010 Aug 23.

    PMID: 20736189BACKGROUND

  • Voelbel GT, Genova HM, Chiaravalotti ND, Hoptman MJ. Diffusion tensor imaging of traumatic brain injury review: implications for neurorehabilitation. NeuroRehabilitation. 2012;31(3):281-93. doi: 10.3233/NRE-2012-0796.

    PMID: 23093455BACKGROUND

MeSH Terms

Conditions

Brain ConcussionBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Jørgen F Nielsen, Professor

    Region Hospital, Hammel Neurocenter, University Clinic, Voldbyvej 15, 8450 Hammel

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pathology in the brain after mTBI - A multimodal MRI study

Study Record Dates

First Submitted

August 21, 2013

First Posted

September 6, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 21, 2015

Record last verified: 2015-03

Locations

DK(1)