Mild Traumatic Brain InjuryNCT02977728
Olfactory Function in Patients With Acute Mild Traumatic Brain Injury
An observational study of Mild Traumatic Brain Injury, run by Hôpital de Viege.
Trial summary
In this project the investigators aim to evaluate olfactory and non-olfactory function in patients within the first 24h following a mild traumatic brain injury (acute mTBI) and compare their results to a group of age and sex matched control patients suffering from an orthopedic injury 24h prior to testing. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Olfactory Evaluation
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2018
- How long will I take part?
- 1 Year
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: The investigators will include a total of 30 patients with acute (into the first 24 hours) mild TBI and the same number of patients with an orthopaedic injury not involving the head.
Who may be able to join
- The investigators will include patients aged between 18 and 55 years old
- admitted to the Hospital Visp in the 24 hours preceding the testing
- MTBI group: The investigators will include patients who have been diagnosed with a mild traumatic brain injury (Glasgow Coma Scale 13 and above) within 24h before inclusion.
- Orthopaedic Group: The investigators will include patients who have been diagnosed with a traumatic orthopaedic injury to one of their limbs within 24 hours before inclusion.
Who cannot join
- are under the influence of alcohol or drugs during the time of testing
- patients with a known history of traumatic brain injury (e.g., a prior concussion)
- patients with a known and pharmacologically treated neurological or psychiatric diseases
- patients who have suffered from an injury to the face (such as a broken nose)
- patients who do not have German, French or English as their first language
- For the orthopaedic group : The investigators will exclude patients who, in addition to their orthopaedic trauma, have suffered from a brain injury due to their trauma.
About this study
In this project the investigators aim to evaluate olfactory and non-olfactory function in patients within the first 24h following a mild traumatic brain injury (acute mTBI) and compare their results to a group of age and sex matched control patients suffering from an orthopedic injury 24h prior to testing. The investigators then aim to follow them up 1 year after the trauma
Read the detailed description
This is a research project in which health-related personal data is collected; the investigators will use coded data. Further this project is a cross-sectional study.
Procedure Potential participants will be identified via the collaborating physicians who will inquire about the interest of the patient to participate. The investigators will then approach patients in their room and inform them about the study. If the patient is interested they will sign the consent form and be included in the study.
Session 1: Session 1 will be carried out directly after inclusion into the study. First the investigators will execute olfactory tests subjective olfactory impairment, Sniffin' Sticks test (threshold, discrimination, identification) and subjective odor evaluation. This will approximately last one hour (with breaks). Participants will then have a break of 15-60 minutes. In the following the investigators will carry out the non-olfactory tests; this will last another 45 minutes.
Session 2: During inclusion, participants will be asked to give their contact details (email and postal address). 10 months after the first session, the investigators will contact them by email. The investigators will then send them a booklet of the UPSIT by mail. Participants will be asked to fill out the test and send it back with a prepaid envelope.
Recruitment Potential participants will be identified via the collaborating physicians who will inquire about the interest of the patient to participate. The investigators will then approach patients in their room and inform them about the study. If the patient is interested they will sign the consent form and be included in the study. Specifically, the responsible researcher will perform consecutive ongoing recruitment through daily clinical practice. The investigators will also carry out the screening.
Criteria for withdrawal / discontinuation of participants:
The participant participation in this study is strictly voluntary. They may refuse to participate or may discontinue their participation at any time without explanation, and without penalty or loss of benefits to which they are otherwise entitled. If they decide not to participate, or if they discontinue their participation, they will suffer no prejudice regarding medical care or their participation in any other research studies. They will be informed of any new findings that may affect their willingness to continue their participation.
The study doctor may end the participant participation for administrative reasons unrelated to the purpose of the study. In addition, the Swiss Ethics Committees on research involving humans may terminate the study.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Olfactory Evaluation
- Keywords
- MTBI, olfaction, acute
- Medical subject headings
- Brain Concussion, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory EvaluationOther
The investigators will evaluate the olfactory system of all participants by the use of the Sniffin'Sticks batterie
| Study group | Role | What they receive |
|---|---|---|
| Mild Traumatic Brain Injury | The investigators will include patients who have been diagnosed with a mild traumatic brain injury (Glasgow Coma Scale 13 and above). The patients will be aged between 18 and 55 years old and admitted to the Hospital Visp in the 24 hours preceding the testing. Receives: Other: Olfactory Evaluation | |
| Orthopaedic Injury | The investigators will include patients who have been diagnosed with a traumatic orthopedic injury to one of their limbs. The patients will be aged between 18 and 55 years old and admitted to the Hospital Visp in the 24 hours preceding the testing. Receives: Other: Olfactory Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the objective and subjective olfactory function in patients following an acute mild traumatic brain injury
The investigatos will assess several different aspects of olfactory function with the Sniffin' Sticks test.Threshold: At each trial 3 pens are presented in a randomized order, two of which contain the solvent and one the odorant at a certain dilution. The subjects' task is to detect the odour-containing pen.Discrimination: Odour discrimination will be assessed by presenting triplets of pens in a randomized order. Two of them contain the same odorant, while the third contains a different odorant. Subjects have to determine which of the three odour- containing pens smells different. Identification: Odour identification will be assessed by means of common odours, presented in 16 different sticks. Using a forced choice approach, participants will select the best descriptor from a list of four for each odorant.Subjective olfactory impairment:The investigators will use an adapted version of the Questionnaire of Olfactory Disorders to determine the changes in olfactory function.
Measured: The investigators will evaluate the olfactory system within 24h following the trauma
Secondary outcomes (4)
Evaluate the anxiety levels in patients following an acute mild traumatic brain injury
The investigators will assess anxiety levels by using the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depressionAlso, the Hamilton Anxiety Rating Scale, a 14-item scale designed to assess anxiety severity, will be administered by the examiner. It has been suggested to reflect subclinical expression of anxiety disorders.
Measured: The investigators will evaluate the anxiety levels within 24h following the trauma
Evaluate the cognitive profil of the patients following an acute mild traumatic brain injury
The Trail Making Test version A and B will be use in order to evaluate visual attention and task switching. This test consists of connecting dots carrying numbers and letters. We will further use the Stroop test to evaluate inhibition and interference in our participants. In addition we will use the Digit symbol substitution test, which measures speed of information processing. Finally, we will assess working memory, attention and mental control by using the letter number sequencing portion of the WAIS. All these tests have been shown to be sensitive to TBI. We will further evaluate cognitive impairment by means of the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status). Offering valuable enhancements, the RBANS Update provides a brief, individually administered battery to measure the general cognitive profil.
Measured: The investigators will evaluate the cognitive profils within 24h following the trauma
Evaluate the post-concussion symptoms in patients following an acute mild traumatic brain injury
The investigators will use the Rivermead post-concussion symptoms questionnaire. It allows for determining the presence and severity of 16 post-concussion symptoms including somatic, cognitive and emotional symptoms
Measured: The investigators will evaluate the post-concussion symptoms within 24h following the trauma
Evaluate the olfactory system one year post-tbi by the use of the UPSIT
The investigators will send by mail the UPSIT: The University of Pennsylvania Smell Identification Test (UPSIT) one year post-injury. The UPSIT is a "scratch and sniff" test based on microencapsulated odorants which are released from the surface of strips by means of a pencil. The patient is asked to choose 40 odorants on a multiple-choice list comprising four items each.
Measured: One year after the mild traumatic brain Injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionApr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hôpital de Viege
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Frasnelli, Ph.D., Study director, Sacre-Coeur Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977728
- Sponsor's protocol ID
- 2016-01442
- Other IDs
- 2016
- Status last verified
- Aug 2018
- First submitted
- 17 Nov 2016
- Last updated
- 8 Aug 2018
- 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 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Function in Patients With Acute Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02977728
- Acronym / sponsor ID
- 2016-01442
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- MTBI, olfaction, acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hôpital de ViegeUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 30 Nov 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.
In this project the investigators aim to evaluate olfactory and non-olfactory function in patients within the first 24h following a mild traumatic brain injury (acute mTBI) and compare their results to a group of age and sex matched control patients suffering from an orthopedic injury 24h prior to testing. The investigators then aim to follow them up 1 year after the trauma
Detailed description
This is a research project in which health-related personal data is collected; the investigators will use coded data. Further this project is a cross-sectional study.
Procedure Potential participants will be identified via the collaborating physicians who will inquire about the interest of the patient to participate. The investigators will then approach patients in their room and inform them about the study. If the patient is interested they will sign the consent form and be included in the study.
Session 1: Session 1 will be carried out directly after inclusion into the study. First the investigators will execute olfactory tests subjective olfactory impairment, Sniffin' Sticks test (threshold, discrimination, identification) and subjective odor evaluation. This will approximately last one hour (with breaks). Participants will then have a break of 15-60 minutes. In the following the investigators will carry out the non-olfactory tests; this will last another 45 minutes.
Session 2: During inclusion, participants will be asked to give their contact details (email and postal address). 10 months after the first session, the investigators will contact them by email. The investigators will then send them a booklet of the UPSIT by mail. Participants will be asked to fill out the test and send it back with a prepaid envelope.
Recruitment Potential participants will be identified via the collaborating physicians who will inquire about the interest of the patient to participate. The investigators will then approach patients in their room and inform them about the study. If the patient is interested they will sign the consent form and be included in the study. Specifically, the responsible researcher will perform consecutive ongoing recruitment through daily clinical practice. The investigators will also carry out the screening.
Criteria for withdrawal / discontinuation of participants:
The participant participation in this study is strictly voluntary. They may refuse to participate or may discontinue their participation at any time without explanation, and without penalty or loss of benefits to which they are otherwise entitled. If they decide not to participate, or if they discontinue their participation, they will suffer no prejudice regarding medical care or their participation in any other research studies. They will be informed of any new findings that may affect their willingness to continue their participation.
The study doctor may end the participant participation for administrative reasons unrelated to the purpose of the study. In addition, the Swiss Ethics Committees on research involving humans may terminate the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Traumatic Brain Injury | – | Other: Olfactory EvaluationThe investigators will include patients who have been diagnosed with a mild traumatic brain injury (Glasgow Coma Scale 13 and above). The patients will be aged between 18 and 55 years old and admitted to the Hospital Visp in the 24 hours preceding the testing. |
| Orthopaedic Injury | – | Other: Olfactory EvaluationThe investigators will include patients who have been diagnosed with a traumatic orthopedic injury to one of their limbs. The patients will be aged between 18 and 55 years old and admitted to the Hospital Visp in the 24 hours preceding the testing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The investigators will include a total of 30 patients with acute (into the first 24 hours) mild TBI and the same number of patients with an orthopaedic injury not involving the head.
Key inclusion criteria (4 listed)
- The investigators will include patients aged between 18 and 55 years old
- admitted to the Hospital Visp in the 24 hours preceding the testing
- MTBI group: The investigators will include patients who have been diagnosed with a mild traumatic brain injury (Glasgow Coma Scale 13 and above) within 24h before inclusion.
- Orthopaedic Group: The investigators will include patients who have been diagnosed with a traumatic orthopaedic injury to one of their limbs within 24 hours before inclusion.
Key exclusion criteria (6 listed)
- are under the influence of alcohol or drugs during the time of testing
- patients with a known history of traumatic brain injury (e.g., a prior concussion)
- patients with a known and pharmacologically treated neurological or psychiatric diseases
- patients who have suffered from an injury to the face (such as a broken nose)
- patients who do not have German, French or English as their first language
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 |
|---|---|---|
| Olfactory EvaluationThe investigators will evaluate the olfactory system of all participants by the use of the Sniffin'Sticks batterie | Other | Mild Traumatic Brain Injury, Orthopaedic Injury |
Primary outcome
Evaluate the objective and subjective olfactory function in patients following an acute mild traumatic brain injury
Time frame: The investigators will evaluate the olfactory system within 24h following the trauma
The investigatos will assess several different aspects of olfactory function with the Sniffin' Sticks test.Threshold: At each trial 3 pens are presented in a randomized order, two of which contain the solvent and one the odorant at a certain dilution. The subjects' task is to detect the odour-containing pen.Discrimination: Odour discrimination will be assessed by presenting triplets of pens in a randomized order. Two of them contain the same odorant, while the third contains a different odorant. Subjects have to determine which of the three odour- containing pens smells different. Identification: Odour identification will be assessed by means of common odours, presented in 16 different sticks. Using a forced choice approach, participants will select the best descriptor from a list of four for each odorant.Subjective olfactory impairment:The investigators will use an adapted version of the Questionnaire of Olfactory Disorders to determine the changes in olfactory function.
4 secondary outcomes
Evaluate the anxiety levels in patients following an acute mild traumatic brain injury
Time frame: The investigators will evaluate the anxiety levels within 24h following the trauma
Evaluate the cognitive profil of the patients following an acute mild traumatic brain injury
Time frame: The investigators will evaluate the cognitive profils within 24h following the trauma
Evaluate the post-concussion symptoms in patients following an acute mild traumatic brain injury
Time frame: The investigators will evaluate the post-concussion symptoms within 24h following the trauma
Evaluate the olfactory system one year post-tbi by the use of the UPSIT
Time frame: One year after the mild traumatic brain Injury
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 8 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Mild Traumatic Brain Injury
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
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.
Johannes Frasnelli, Ph.D. study director
Sacre-Coeur Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Hôpital de Viege.
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 6 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate the objective and subjective olfactory function in patients following an acute mild traumatic brain injury (time frame: The investigators will evaluate the olfactory system within 24h following the trauma). 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 Aug 2018.