Brain ConcussionNCT02350894
Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury
An observational study of Brain Concussion, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study examines the possible microstructural changes in the brain during recovery after mTBI using diffusion MRI. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Graded and behavevial theraphy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to 1 May 2018
- 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
- No healthy volunteers
- Adult
Study population: Mild traumatic brain injury subjects with ongoing symptoms 2-6 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 2-6 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the possible microstructural changes in the brain during recovery after mTBI using diffusion MRI.
Read the 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.
- Conditions
- Brain Concussion
- Being tested
- Graded and behavevial theraphy
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded and behavevial theraphyBehavioural
Graded and behavevial theraphy
| Study group | Role | What they receive |
|---|---|---|
| mTBI subjects | mTBI subjects with ongoing symptoms Receives: Behavioral: Graded and behavevial theraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microstructural changes in the thalamus, corpus callosum and hippocampus between baseline and follow up, as measured by Diffusion kurtosis imaging (DKI)
MRI measurement
Measured: Baseline 2-6 month after mTBI with follow up 6 month after
Secondary outcomes (3)
Microstructural changes in the thalamus, corpus callosum and hippocampus from baseline to follow up, as measured by Diffusion tensor imaging (DTI)
MRI measurement
Measured: Baseline 2-6 month after mTBI with follow up 6 month after
Change in post-concussion symptoms from baseline to follow up, as measured by Rivermead post-concussion questionnaire (RPQ) and headache (VAS scale)
Symptom score
Measured: Baseline 2-6 month after mTBI with follow up 6 month after
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
Cognitive test battery
Measured: Baseline 2-6 month after mTBI with follow up 6 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jørgen F Nielsen, Professor, Principal investigator, Hammel Neurocenter - Universitetsklinik for Neurorehabilitering, Aarhus Universi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350894
- Sponsor's protocol ID
- 1-10-72-139-14
- Status last verified
- Oct 2016
- First submitted
- 19 Jan 2015
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Trillingsgaard Naess-Schmidt E, Udby Blicher J, Moller Thastum M, Ulrikka Rask C, Wulff Svendsen S, Schroder A, Hogh Tuborgh A, Ostergaard L, Sangill R, Lund T, Norhoj Jespersen S, Roer Pedersen A, Hansen B, Fristed Eskildsen S, Feldbaek Nielsen J. Microstructural changes in the brain after long-term post-concussion symptoms: A randomized trial. J Neurosci Res. 2021 Mar;99(3):872-886. doi: 10.1002/jnr.24773. Epub 2020 Dec 15.
PubMed 33319932
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02350894
- Acronym / sponsor ID
- 1-10-72-139-14
- Conditions
- Brain Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter, Aarhus University Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 30 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 examines the possible microstructural changes in the brain during recovery after mTBI using diffusion MRI.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mTBI subjects | – | Behavioral: Graded and behavevial theraphymTBI subjects with ongoing symptoms |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mild traumatic brain injury subjects with ongoing symptoms 2-6 months after trauma
Key inclusion criteria (5 listed)
- Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri within the last 2-6 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded and behavevial theraphyGraded and behavevial theraphy | Behavioural | mTBI subjects |
Primary outcome
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
3 secondary outcomes
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
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
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
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 24 May 2018.
- Derived from this study: PubMed 33319932Trillingsgaard Naess-Schmidt E, Udby Blicher J, Moller Thastum M, Ulrikka Rask C, Wulff Svendsen S, Schroder A, Hogh Tuborgh A, Ostergaard L, Sangill R, Lund T, Norhoj Jespersen S, Roer Pedersen A, Hansen B, Fristed Eskildsen S, Feldbaek Nielsen J. Microstructural changes in the brain after long-term post-concussion symptoms: A randomized trial. J Neurosci Res. 2021 Mar;99(3):872-886. doi: 10.1002/jnr.24773. Epub 2020 Dec 15.
- Hammel Neurorehabilitation Centre and University Research Clinic, Aarhus UniversityLink provided by the sponsor.
- The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University HospitalLink provided by the sponsor.
- Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus University HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jørgen F Nielsen, Professor principal investigator
Hammel Neurocenter - Universitetsklinik for Neurorehabilitering, Aarhus Universi
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 5 inclusion and 4 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 24 May 2018. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02350894, which also lists 1 linked publication.
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 24 May 2018.