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Olfactory Function in Patients With Acute Mild Traumatic Brain Injury

2016-12-01 16:08:22 | BioPortfolio

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

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

Conditions

Mild Traumatic Brain Injury

Intervention

Olfactory Evaluation

Status

Not yet recruiting

Source

Hôpital de Viege

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-01T16:08:22-0500

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Medical and Biotech [MESH] Definitions

Prolonged unconsciousness from which the individual cannot be aroused, associated with traumatic injuries to the BRAIN. This may be defined as unconsciousness persisting for 6 hours or longer. Coma results from injury to both cerebral hemispheres or the RETICULAR FORMATION of the BRAIN STEM. Contributing mechanisms include DIFFUSE AXONAL INJURY and BRAIN EDEMA. (From J Neurotrauma 1997 Oct;14(10):699-713)

A form of acquired brain injury which occurs when a sudden trauma causes damage to the brain.

Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits.

Traumatic injuries to the cranium where the integrity of the skull is not compromised and no bone fragments or other objects penetrate the skull and dura mater. This frequently results in mechanical injury being transmitted to intracranial structures which may produce traumatic brain injuries, hemorrhage, or cranial nerve injury. (From Rowland, Merritt's Textbook of Neurology, 9th ed, p417)

Traumatic injuries to the OLFACTORY NERVE. It may result in various olfactory dysfunction including a complete loss of smell.

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