Mild Traumatic Brain InjuryNCT02868684
Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study
An observational study of Mild Traumatic Brain Injury and Posttraumatic Stress Disorder, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This longitudinal cohort study aims to detect the topographical nature of the white matter microstructure and resting state functional connectivity patterns across the whole brain in the evolution of pathology as a function of time following mild TBI. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury, Posttraumatic Stress Disorder, Affective and Somatic Complaints
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Sep 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All consecutively patients with the non-contrast head CT because of acute head trauma from the local emergency department (ED) formed the initial population of this study. Three research assistants (trained, board-certified neurologist or neurosurgeon) monitored the ED and hospital wards on a daily basis to identify new admissions. Screening for mild traumatic brain injury (TBI) was based on the World Health Organization's Collaborating Centre for Neurotrauma Task Force.
Who may be able to join
- Glasgow Coma Score of 13-15;
- one or more of the following: loss of consciousness (if present) < 30 min, post-traumatic amnesia (if present) < 24 h, and/or other transient neurological abnormalities such as focal signs, seizure, and intracranial lesion not requiring surgery.
- no contraindications to MRI;
- injury within 7 days;
- agreement to communicate by telephone or e-mail for 1, 3 to 6-12 months after enrollment and come back to the hospital for follow-up
Who cannot join
- history of neurological disease
- head injury, or history of substance or alcohol abuse, intubation and/or presence of a skull fracture
- administration of sedatives on arrival in the emergency department
- spinal cord injury, manifestation of mild TBI due to other injuries (e.g., systemic injuries, facial injuries, or intubation) or other problems (e.g., psychological trauma, language barrier, or coexisting medical conditions), or caused by penetrating craniocerebral injury.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Multi-modality Magnetic Resonance Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study
This longitudinal cohort study aims to detect the topographical nature of the white matter microstructure and resting state functional connectivity patterns across the whole brain in the evolution of pathology as a function of time following mild TBI. All consecutively patients with the non-contrast head CT because of acute head trauma from the local emergency department (ED) formed the initial population of this study. Age, sex, education-level matched healthy controls will also be enrolled. The initial scan will performed within 7 days post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1 month, 3 month, 6-12 months.
- Conditions
- Mild Traumatic Brain Injury, Posttraumatic Stress Disorder, Affective and Somatic Complaints, Cognitive Impairments
- Medical subject headings
- Brain Concussion, Stress Disorders, Post-Traumatic, Cognitive Dysfunction
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 |
|---|---|---|
| mild traumatic brain injury | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom
Measured: 1 month
Secondary outcomes (3)
Changes in post-concussive symptoms
Measured: baseline, 1 month
changes in affective complaints
Measured: baseline and follow-up
Changes in somatic complaints
Measured: baseline and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2020
- Study completionSep 2020
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 Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhang, M.D, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868684
- Sponsor's protocol ID
- NSFC81571752-1
- Status last verified
- May 2022
- First submitted
- 9 Aug 2016
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Niu X, Bai L, Sun Y, Wang Y, Bai G, Yin B, Wang S, Gan S, Jia X, Liu H. Mild traumatic brain injury is associated with effect of inflammation on structural changes of default mode network in those developing chronic pain. J Headache Pain. 2020 Nov 23;21(1):135. doi: 10.1186/s10194-020-01201-7.
PubMed 33228537
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modality Magnetic Resonance Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT02868684
- Acronym / sponsor ID
- NSFC81571752-1
- Conditions
- Mild Traumatic Brain Injury, Posttraumatic Stress Disorder, Affective and Somatic Complaints, Cognitive Impairments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Wenzhou Medical University
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 16 Aug 2016 (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 longitudinal cohort study aims to detect the topographical nature of the white matter microstructure and resting state functional connectivity patterns across the whole brain in the evolution of pathology as a function of time following mild TBI. All consecutively patients with the non-contrast head CT because of acute head trauma from the local emergency department (ED) formed the initial population of this study. Age, sex, education-level matched healthy controls will also be enrolled. The initial scan will performed within 7 days post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1 month, 3 month, 6-12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild traumatic brain injury | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutively patients with the non-contrast head CT because of acute head trauma from the local emergency department (ED) formed the initial population of this study. Three research assistants (trained, board-certified neurologist or neurosurgeon) monitored the ED and hospital wards on a daily basis to identify new admissions. Screening for mild traumatic brain injury (TBI) was based on the World Health Organization's Collaborating Centre for Neurotrauma Task Force.
Key inclusion criteria (5 listed)
- Glasgow Coma Score of 13-15;
- one or more of the following: loss of consciousness (if present) < 30 min, post-traumatic amnesia (if present) < 24 h, and/or other transient neurological abnormalities such as focal signs, seizure, and intracranial lesion not requiring surgery.
- no contraindications to MRI;
- injury within 7 days;
- agreement to communicate by telephone or e-mail for 1, 3 to 6-12 months after enrollment and come back to the hospital for follow-up
Key exclusion criteria (4 listed)
- history of neurological disease
- head injury, or history of substance or alcohol abuse, intubation and/or presence of a skull fracture
- administration of sedatives on arrival in the emergency department
- spinal cord injury, manifestation of mild TBI due to other injuries (e.g., systemic injuries, facial injuries, or intubation) or other problems (e.g., psychological trauma, language barrier, or coexisting medical conditions), or caused by penetrating craniocerebral injury.
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
Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom
Time frame: 1 month
3 secondary outcomes
Changes in post-concussive symptoms
Time frame: baseline, 1 month
changes in affective complaints
Time frame: baseline and follow-up
Changes in somatic complaints
Time frame: baseline and follow-up
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 12 May 2022.
- Derived from this study: PubMed 33228537Niu X, Bai L, Sun Y, Wang Y, Bai G, Yin B, Wang S, Gan S, Jia X, Liu H. Mild traumatic brain injury is associated with effect of inflammation on structural changes of default mode network in those developing chronic pain. J Headache Pain. 2020 Nov 23;21(1):135. doi: 10.1186/s10194-020-01201-7.
- Individual participant dataSharing planned: Undecided
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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.
Ming Zhang, M.D principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 Mild Traumatic Brain Injury and Posttraumatic Stress Disorder, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 12 May 2022. 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 China. 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?
Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom (time frame: 1 month). 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 NCT02868684, 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 12 May 2022.