Pediatric Concussion & Olfaction: Investigation of the effect of mild traumatic brain injury on olfaction in children and adolescents in the acute phase up to three months after the trauma

Pediatric Concussion & Olfaction: Investigation of the effect of mild traumatic brain injury on olfaction in children and adolescents in the acute phase up to three months after the trauma - Pediatric Concussion & Olfaction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035751

Enrollment

180

Registered

2024-12-18

Start date

2022-11-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S06.0

Interventions

Group 1: Investigation of the effect of mild traumatic brain injury on olfaction in children and adolescents in the acute phase up to three months after the trauma at a total of 3 test time points (<

Eligibility

Sex/Gender

All

Age

6 Years to 17 Years

Inclusion criteria

Inclusion criteria: Physician diagnosed mild TBI (GCS 13-15, symptoms of neurological dysfunction following direct or indirect head trauma) The TBI was not more than 72 hours ago at the time of the initial examination Written informed consent of the legal guardians and the study participants.

Exclusion criteria

Exclusion criteria: Patients: Intentional violence as the cause of the TBI Previous mild TBI in the past 24 months, Previous moderate or severe TBI in medical history All: Acute upper respiratory tract infection with rhinitis Pre-existing impairment of olfaction Neurological or serious preexisting condition

Design outcomes

Primary

Measure	Time frame
Comparison of the scores achieved in the olfactory threshold test at time T1 between the patient and control groups.	—

Secondary

Measure	Time frame
Comparison of the scores of the odor threshold test between the two groups at time points T2 and T3. Comparison of the scores of the two other odor subtests (odor discrimination, odor identification) as well as the total score (sum of the results of all 3 subtests [TDI score]) between the two groups at time points T1, T2 and T3. Comparison of the total score and the 3 subtest scores of the patient group with the percentile data of the norm collective. Comparison of the total score and the subtest scores in the patient group between the time points T1 and T2 or T2 and T3 (mapping the trajectory). Identification of possible associations between performance in the smell test and the clinical data incl. quality of life.	—

Measure

Time frame

Comparison of the scores of the odor threshold test between the two groups at time points T2 and T3. Comparison of the scores of the two other odor subtests (odor discrimination, odor identification) as well as the total score (sum of the results of all 3 subtests [TDI score]) between the two groups at time points T1, T2 and T3. Comparison of the total score and the 3 subtest scores of the patient group with the percentile data of the norm collective. Comparison of the total score and the subtest scores in the patient group between the time points T1 and T2 or T2 and T3 (mapping the trajectory). Identification of possible associations between performance in the smell test and the clinical data incl. quality of life.

—

Countries

Germany

Contacts

Public ContactMichaela Bonfert

LMU Klinikum, Dr. von Haunersches Kinderspital,Abteilung für Pädiatrische Neurologie

michaela.bonfert@med.lmu.de089 4400 56760

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026