Functional and structural brain network parameters as prognostic factors in Traumatic Brain Injury (TBI)

Completed

• Conditions: intracranial injury; traumatic brain injury; 10022114

• Registration Number: NL-OMON34259
• Lead Sponsor: Radboud Universiteit Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

- Age >= 18 years and <= 65 years
- Gender: male and female
- Patients who were diagnosed a moderate or severe TBI > 1 year ago (only applicable to patients)
- Physical and cognitive abilities to undertake neuropsychological testing
- Willingness and ability to give written informed consent and willingness and ability to understand the nature and content, to participate and to comply with the study requirements

Exclusion Criteria

- History of severe neurological or somatic disease
- Psychiatric diagnosis (current and past)
- Neurosurgical operations in past
- Chronic alcohol or drug abuse
- Everyday smoking
- Current use of any psychotropic drug
- Penetrating injury to the skull
- Pregnancy
- Metal objects in or around the body (braces, pacemaker, metal fragments, hearing devices)
- Claustrophobia

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>From the functional and structural connectivity networks the following network<br /><br>parameters will be assessed:<br /><br>- Centrality of the removed nodes (regions). Centrality of a node measures how<br /><br>many of the shortest paths between all over node pairs in the network pass<br /><br>through it.<br /><br>- Number of connections between the lesion site and the rest of the brain, that<br /><br>were lost.<br /><br>- Local and nodal efficiency in the remaining network as the measure of its<br /><br>robustness.<br /><br><br /><br>The global clinical outcome of TBI patients will be evaluated using:<br /><br>- extended Glasgow Outcome Scale (GOSE)<br /><br>- functional independence measurement (FIM) score<br /><br>- neurological examination.<br /><br><br /><br>A battery of neuropsychological tests will be performed to assess the outcome<br /><br>in:<br /><br>- memory and executive function<br /><br>- attention<br /><br>- intellectual function<br /><br>- speech/language.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The association between genetic polymorphisms and outcome.</p><br>