Brain ConcussionNCT02331901
Cerebral Microstructural Changes Following Mild Traumatic Brain Injury
An observational study of Brain Concussion, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study examine the possible microstructural changes in the middle brain after mTBI using diffusion MRI Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Mild traumatic brain injury subjects with and without symptoms 3-4 months after trauma
Who may be able to join
- 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.
Who cannot join
- 1. 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
Trial locations and contacts
1 site in 1 country.
About this study
This study examine the possible microstructural changes in the middle brain after mTBI using diffusion MRI
Read the detailed description
There is a need for clinical and biological markers at 2-3 month to screen people in risk of getting chronic post-concussion symptoms (PCS) but also biomarkers in the brain to find out if this group with prolonged symptoms has measurable changes in the brain which could explain the persisting symptoms.
Several biomarkers and brain areas have been investigated as possible sites of injury after mild traumatic brain injury (mTBI). The nature of the diffuse 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 later phase. Diffusional Kurtosis Imaging (DKI) and Diffusional Tensor Imaging (DTI) are more sensitive to microstructural changes and might serve as biomarkers in the middle brain after mTBI.
It is hypothesized that there will be a difference in the microstructure of the thalamus, corpus callosum and hippo campus as measured with DKI between two groups of mTBI subjects with and without PCS. Secondary it is hypothesized that DKI are more sensitive than DTI in the measure of microstructural changes.
- Conditions
- Brain Concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MTBI SYMP | Mild Traumatic Brain Injury subjects with symptoms | |
| MTBI NO SYMP | Mild Traumatic Brain Injury subjects without symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion kurtosis Imaging (DKI)
MRI measurement unit
Measured: 2-5 month after mTBI
Secondary outcomes (1)
Diffusion Tensor Imaging (DTI)
MRI measurement unit
Measured: 2-5 month after mTBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhard Trillingsgaard Næss-Schmidt, University of Aarhus
- Investigators
- Erhard T Næss-Schmidt, PhD fellow, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331901
- Sponsor's protocol ID
- mtbi-1
- Status last verified
- Oct 2016
- First submitted
- 23 Dec 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Microstructural Changes Following Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02331901
- Acronym / sponsor ID
- mtbi-1
- Conditions
- Brain Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examine the possible microstructural changes in the middle brain after mTBI using diffusion MRI
Detailed description
There is a need for clinical and biological markers at 2-3 month to screen people in risk of getting chronic post-concussion symptoms (PCS) but also biomarkers in the brain to find out if this group with prolonged symptoms has measurable changes in the brain which could explain the persisting symptoms.
Several biomarkers and brain areas have been investigated as possible sites of injury after mild traumatic brain injury (mTBI). The nature of the diffuse 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 later phase. Diffusional Kurtosis Imaging (DKI) and Diffusional Tensor Imaging (DTI) are more sensitive to microstructural changes and might serve as biomarkers in the middle brain after mTBI.
It is hypothesized that there will be a difference in the microstructure of the thalamus, corpus callosum and hippo campus as measured with DKI between two groups of mTBI subjects with and without PCS. Secondary it is hypothesized that DKI are more sensitive than DTI in the measure of microstructural changes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTBI SYMP | – | –Mild Traumatic Brain Injury subjects with symptoms |
| MTBI NO SYMP | – | –Mild Traumatic Brain Injury subjects without symptoms |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Mild traumatic brain injury subjects with and without symptoms 3-4 months after trauma
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 1. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diffusion kurtosis Imaging (DKI)
Time frame: 2-5 month after mTBI
MRI measurement unit
1 secondary outcome
Diffusion Tensor Imaging (DTI)
Time frame: 2-5 month after mTBI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Brain Concussion
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Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhard T Næss-Schmidt, PhD fellow principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion kurtosis Imaging (DKI) (time frame: 2-5 month after mTBI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.