Mild Head InjuryNCT02828527
Care Courses for Mild Head Injury Patients
An observational study of Mild Head Injury, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Background / Rationale at. The mild head injury. In France, the incidence of head injuries is estimated at 100,000 per year in France. 80% of mild head trauma. This is a pattern of frequent use of the health system. The reason for consultation, benign appearance, present a significant risk of complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Head Injury
- What is being tested?
- Observational
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2014to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to emergency Unit of Hopital Paris Saint Jospeh
Who may be able to join
None listed.
Who cannot join
- <18
- Major Trust
- Context of acute alcohol (> 3 glasses) or toxic taking (drugs)
- Not understanding or communication
- Patient Refusal
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Background / Rationale at. The mild head injury.
In France, the incidence of head injuries is estimated at 100,000 per year in France. 80% of mild head trauma. This is a pattern of frequent use of the health system. The reason for consultation, benign appearance, present a significant risk of complication. In 15 to 25% of the evolution of head injury is unfavorable. Disorders of attention, memory disorders, psychiatric events and mood changes may occur. These symptoms are grouped into a syndrome, post-concussion syndrome.
Read more
The post-concussion syndrome:
It affects approximately 20,000 people per year in France. This is a common disease and most undervalued in the general population. diagnostic criteria post-concussional disorder according to DSM-IV (Diagnostic and Statistical Manual). Symptoms may persist for more than 3 months after head injury. This syndrome is responsible for suffering, personal and professional sound and quality of life of patients. It is particularly debilitating in everyday life, and can have disastrous consequences on their family, social, cultural and professional. It gives rise to many financial implications with compensation requirements and expertise consultations.
Intention of work In a recent study by a team of neuropsychologists Kremlin Bicetre, it has been shown that screening and early treatment of post-concussion syndrome from the slight head injury prevents chronicity of symptoms.
Read the detailed description
Methodology :
Design: Cohort study single-center prospective observational. Recruitment period: 15/11/2014 to 15/12/2014 approximately (50 records necessary).
Then follow a month is required. Either theoretical study end: 01/15/2015.
Acquisition of data:
Pre inclusion of patients in the study by sorting CAE emergency department on the following host pattern: traumatic brain injury with loss of consciousness, traumatic brain injury without loss of consciousness, with loss of consciousness discomfort, discomfort without a loss of consciousness peripheral vascular accident PVA.
Collection address, telephone number and an e-mail address of the patient (after delivery of a newsletter).
call the patient and questionnaire submitted between 0 and J15 and J15 and J30 between.
- Conditions
- Mild Head Injury
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in Glasgow score
Measured: submitted between Day 0 and Day 15 and between Day 15 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start12 Sep 2014
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Head InjuryStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AÏM Jean luc, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828527
- Sponsor's protocol ID
- Parcours TC léger
- Status last verified
- Mar 2018
- First submitted
- 7 Jul 2016
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Courses for Mild Head Injury Patients
- ClinicalTrials.gov ID
- NCT02828527
- Acronym / sponsor ID
- Parcours TC léger
- Conditions
- Mild Head Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 12 Sep 2014 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 11 Jul 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.
Background / Rationale at. The mild head injury.
In France, the incidence of head injuries is estimated at 100,000 per year in France. 80% of mild head trauma. This is a pattern of frequent use of the health system. The reason for consultation, benign appearance, present a significant risk of complication. In 15 to 25% of the evolution of head injury is unfavorable. Disorders of attention, memory disorders, psychiatric events and mood changes may occur. These symptoms are grouped into a syndrome, post-concussion syndrome.
The post-concussion syndrome:
It affects approximately 20,000 people per year in France. This is a common disease and most undervalued in the general population. diagnostic criteria post-concussional disorder according to DSM-IV (Diagnostic and Statistical Manual). Symptoms may persist for more than 3 months after head injury. This syndrome is responsible for suffering, personal and professional sound and quality of life of patients. It is particularly debilitating in everyday life, and can have disastrous consequences on their family, social, cultural and professional. It gives rise to many financial implications with compensation requirements and expertise consultations.
Intention of work In a recent study by a team of neuropsychologists Kremlin Bicetre, it has been shown that screening and early treatment of post-concussion syndrome from the slight head injury prevents chronicity of symptoms.
Detailed description
Methodology :
Design: Cohort study single-center prospective observational. Recruitment period: 15/11/2014 to 15/12/2014 approximately (50 records necessary).
Then follow a month is required. Either theoretical study end: 01/15/2015.
Acquisition of data:
Pre inclusion of patients in the study by sorting CAE emergency department on the following host pattern: traumatic brain injury with loss of consciousness, traumatic brain injury without loss of consciousness, with loss of consciousness discomfort, discomfort without a loss of consciousness peripheral vascular accident PVA.
Collection address, telephone number and an e-mail address of the patient (after delivery of a newsletter).
call the patient and questionnaire submitted between 0 and J15 and J15 and J30 between.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to emergency Unit of Hopital Paris Saint Jospeh
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- <18
- Major Trust
- Context of acute alcohol (> 3 glasses) or toxic taking (drugs)
- Not understanding or communication
- Patient Refusal
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 |
|---|---|---|
| Observational | Other | – |
Primary outcome
Assessment of change in Glasgow score
Time frame: submitted between Day 0 and Day 15 and between Day 15 and Day 30
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 14 Mar 2018.
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Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
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Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
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Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
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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.
AÏM Jean luc, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Head Injury, run by Fondation Hôpital Saint-Joseph 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 0 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 14 Mar 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 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?
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?
Assessment of change in Glasgow score (time frame: submitted between Day 0 and Day 15 and between Day 15 and Day 30). 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 14 Mar 2018.