Frontal cerebral hemodynamic changes in adults after mild traumatic brain injury using Functional NearInfrared Spectroscopy (fNIRS); a pilot study.

Completed

• Conditions: (Licht) traumatisch hersenletsel; Mild traumatic brain injury - concussion

• Registration Number: NL-OMON45790
• Lead Sponsor: MC Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Traumatic brain injury
Glasgow Coma Scale score 13-15 at Emergency Department admittance
Age 18 years and older
Recovered from posttraumatic amnesia (PTA)
Informed consent by patient

Exclusion Criteria

No permanent residence
Intoxication with or addiction to alcohol and/or drugs
Previous admission for traumatic brain injury
Psychiatric illness including depression
Epilepsia
Severe hypoxia, hypercapnia or anemia
Neurodegenerative disease
No comprehension of Dutch language

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures:<br /><br>a) (Changes in) frontal cerebral perfusion measured using fNIRS (including<br /><br>cognitive tasks) in patients compared to healthy controls.<br /><br>b) Functional outcome three months post-injury, determined using the Glasgow<br /><br>Outcome Scale Extended (GOSE).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures:<br /><br>a) Functional outcome six weeks post-injury, determined using the Glasgow<br /><br>Outcome Scale Extended (GOSE).<br /><br>b) Post-traumatic complaints two weeks and three months post-injury determined<br /><br>using the *Groningen Klachtenlijst*.</p><br>