Brain-damaged PatientsNCT03181373
IRM Cognition in Patients With Head Trauma
An observational study of Brain-damaged Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain-damaged Patients
- What is being tested?
- Cognitive rehabilitation program
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2014to Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with traumatic brain injury
Who may be able to join
- Adult patients, over the age of 18.
- Mild traumatic brain injury (Initial Glasgow score between 9 and 12)
- Severe brain injury (Initial Glasgow score between 3 and 8),
- Diffuse axonal injury and/or focal lesions.
Who cannot join
- Patients with MRI contraindications,
- Antecedents of brain lesions,
- Important lesions of the lobes and cortex on cerebral CT,
- Anoxic lesions related to cardiorespiratory arrest,
- Must be able to perform neuropsychological tests,
- Visual and auditory impairments.
- Aphasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Descriptive Study of the Correlation Between Cognitive Functions, White Matter Anatomical Pathways and Functional Magnetic Resonance Imaging Activations in Patients With Moderate to Severe Head Trauma.
Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period.
Read the detailed description
The following data are collected in 3 months, 12 months then 24 months after the accident with followed data collection :
- Clinical, neuropsychological assessments
- Diffusion magnetic resonance imaging (MRI) for the reconstruction of anatomical pathways
- Functional imaging data.
- Conditions
- Brain-damaged Patients
- Being tested
- Cognitive rehabilitation program
- Keywords
- Craniocerebral injury, Mild and severe brain traumatic injury, Neuropsychological abilities, Clinical assessment, Anatomical and functional imaging
- Medical subject headings
- Craniocerebral Trauma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitation programOther
Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Traumatic brain injury population | Defined population : traumatic brain injury population Receives: Other: Cognitive rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Baseline standardized volume of the white matter fascicles
determined on the "iplan" software. Baseline measured at 3 months after brain traumatic injury.
Measured: at 3, 12 and 24 months
Secondary outcomes (2)
Measure of the volume of activations clusters
during functional MRI for attention, motor, working memory, language tasks.
Measured: at 3, 12 and 24 months
Location of activation clusters
during functional MRI for attention, motor, working memory, language tasks.
Measured: at 3, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start26 Sep 2014
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain-damaged PatientsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Clementel, Maurice Gantchoula, LADAPT, APF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181373
- Sponsor's protocol ID
- CHU-328
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Descriptive Study of the Correlation Between Cognitive Functions, White Matter Anatomical Pathways and Functional Magnetic Resonance Imaging Activations in Patients With Moderate to Severe Head Trauma.
- ClinicalTrials.gov ID
- NCT03181373
- Acronym / sponsor ID
- CHU-328
- Conditions
- Brain-damaged Patients
- Keywords
- Craniocerebral injury, Mild and severe brain traumatic injury, Neuropsychological abilities, Clinical assessment, Anatomical and functional imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Clementel, Maurice Gantchoula, LADAPT, APF
- Study start
- 26 Sep 2014 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Jun 2017 (actual)
- 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.
Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period.
Detailed description
The following data are collected in 3 months, 12 months then 24 months after the accident with followed data collection :
- Clinical, neuropsychological assessments
- Diffusion magnetic resonance imaging (MRI) for the reconstruction of anatomical pathways
- Functional imaging data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury population | – | Other: Cognitive rehabilitation programDefined population : traumatic brain injury population |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with traumatic brain injury
Key inclusion criteria (4 listed)
- Adult patients, over the age of 18.
- Mild traumatic brain injury (Initial Glasgow score between 9 and 12)
- Severe brain injury (Initial Glasgow score between 3 and 8),
- Diffuse axonal injury and/or focal lesions.
Key exclusion criteria (7 listed)
- Patients with MRI contraindications,
- Antecedents of brain lesions,
- Important lesions of the lobes and cortex on cerebral CT,
- Anoxic lesions related to cardiorespiratory arrest,
- Must be able to perform neuropsychological tests,
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 |
|---|---|---|
| Cognitive rehabilitation programRehabilitation | Other | Traumatic brain injury population |
Primary outcome
Changes in Baseline standardized volume of the white matter fascicles
Time frame: at 3, 12 and 24 months
determined on the "iplan" software. Baseline measured at 3 months after brain traumatic injury.
2 secondary outcomes
Measure of the volume of activations clusters
Time frame: at 3, 12 and 24 months
Location of activation clusters
Time frame: at 3, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-damaged Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Jun 2017. 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 France. 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?
Results are not available in the source record.
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?
Changes in Baseline standardized volume of the white matter fascicles (time frame: at 3, 12 and 24 months). 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 8 Jun 2017.