Olfactory Function in Patients With Acute Mild Traumatic Brain Injury

NCT02977728 | Completed DMC

• 1 other identifier: 2016-01442
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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. The investigators then aim to follow them up 1 year after the trauma

Conditions

Mild Traumatic Brain Injury

Keywords

MTBI; olfaction; acute

Outcome Measures

Primary Outcomes (1)

• 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.

  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 evaluate the anxiety levels within 24h following the trauma

• Evaluate the cognitive profil of the patients following an acute mild traumatic brain injury

  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 evaluate the post-concussion symptoms within 24h following the trauma

• Evaluate the olfactory system one year post-tbi by the use of the UPSIT

  One year after the mild traumatic brain Injury

Study Arms (2)

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.

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.

Other: Olfactory Evaluation

Interventions

Olfactory Evaluation OTHER

The investigators will evaluate the olfactory system of all participants by the use of the Sniffin'Sticks batterie

Mild Traumatic Brain Injury; Orthopaedic Injury

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• The investigators will include patients aged between 18 and 55 years old
• admitted to the Hospital Visp in the 24 hours preceding the testing

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital de Viege: lead

MeSH Terms

Conditions

Brain Concussion; Anosmia

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Johannes Frasnelli, Ph.D.

  Sacre-Coeur Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 30, 2016
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share