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Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by University of Aarhus
Sponsor:
Collaborators:
Regionshospitalet Hammel Neurocenter
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02350894
First received: January 19, 2015
Last updated: October 25, 2016
Last verified: October 2016
  Purpose
This study examines the possible microstructural changes in the brain during recovery after mTBI using diffusion MRI.

Condition
Brain Concussion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Microstructural changes in the thalamus, corpus callosum and hippocampus between baseline and follow up, as measured by Diffusion kurtosis imaging (DKI) [ Time Frame: Baseline 2-6 month after mTBI with follow up 6 month after ]
    MRI measurement


Secondary Outcome Measures:
  • Microstructural changes in the thalamus, corpus callosum and hippocampus from baseline to follow up, as measured by Diffusion tensor imaging (DTI) [ Time Frame: Baseline 2-6 month after mTBI with follow up 6 month after ]
    MRI measurement

  • Change in post-concussion symptoms from baseline to follow up, as measured by Rivermead post-concussion questionnaire (RPQ) and headache (VAS scale) [ Time Frame: Baseline 2-6 month after mTBI with follow up 6 month after ]
    Symptom score

  • Change in Cognitive performance from baseline to follow up, as measured by executive function, verbal and visual memory, processing speed, working memory, Visuospatial perception and construction [ Time Frame: Baseline 2-6 month after mTBI with follow up 6 month after ]
    Cognitive test battery


Estimated Enrollment: 50
Study Start Date: January 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
mTBI subjects
mTBI subjects with ongoing symptoms

Detailed Description:

This study is embedded in a larger randomized controlled trial (RCT) (ClinicalTrials.gov ID: NCT02337101) from which the subjects are recruited and will separately examine the possible microstructural changes in the brain during recovery after mild traumatic brain injury (mTBI) in subjects with ongoing symptoms more than 2 month after mTBI in both groups from the RCT.

Several biomarkers and brain areas has been investigated as possible sites of injury after mTBI. The nature of the diffuse chronic post-concussion symptoms (PCS) makes corpus callosum (CC), thalamus (THA) and hippocampus (HIP) interesting because of their central position and connection to widespread motor, sensory and cognitive processes and other brain areas. In most prior studies conventional magnetic resonance imaging (MRI) has failed to detect pathology especially in the chronic phase after mTBI. Diffusional Kurtosis Imaging (DKI) and Diffusional Tensor Imaging (DTI) are more sensitive to microstructural changes and might serve as biomarkers in the brain after mTBI.

We hypothesized that a change in symptoms (as measured by cognitive performance and self reported symptoms) will correlate with a change in microstructural changes (as measured with DKI) in thalamus, corpus callosum and hippocampus from baseline 2-6 month after mTBI to follow up 6 month after.

Separate correlations will also be made for both treatment and control group within the cohort.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mild traumatic brain injury subjects with ongoing symptoms 2-6 months after trauma
Criteria

Inclusion Criteria:

  • Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri within the last 2-6 months. The criteria are based on 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 pure 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 on 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.
  • Suitable for MRI examination

Exclusion Criteria:

  • Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating other neurological diseases or brain damage.
  • Previous concussion leading to persistent PCS within the last two years.
  • Severe abuse 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 (lifetime), multiple sclerosis etc.
  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: NCT02350894

Contacts
Contact: Erhard T Næss-Schmidt, PhD fellow +45 78419062 erhnae@rm.dk

Locations
Denmark
Region Hospital Hammel Neurocenter Recruiting
Hammel, Denmark, 8450
Contact: Erhard Næss-Schmidt, PhD fellow    +45 78419062    erhnae@rm.dk   
Sub-Investigator: Erhard T Næss-Schmidt, PhD fellow         
Principal Investigator: Jørgen F Nielsen, Professor         
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Hammel Neurocenter
Aarhus University Hospital
Investigators
Principal Investigator: Jørgen F Nielsen, Professor Hammel Neurocenter - Universitetsklinik for Neurorehabilitering, Aarhus Universi
  More Information

Additional Information:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02350894     History of Changes
Other Study ID Numbers: 1-10-72-139-14
Study First Received: January 19, 2015
Last Updated: October 25, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on September 19, 2017