An interventional study of Infrascanner in Ischemic Stroke, Brain Tumor and Brain Surgery, sponsored by Ziekenhuis Oost-Limburg. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2017-03-14.
Sponsored by Ziekenhuis Oost-Limburg · Not applicable, Interventional, and Diagnostic
The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to positive and negative predictive value of the Infrascanner in these different settings.
Infrascanner is a portable device initially designed to detect intracranial hemorrhage in battlefield traumas. Infrascanner uses near infrared spectroscopy to measure cerebral blood flow non-invasively. This is achieved by putting the device against the scalp in 4 different areas (frontal, temporal, parietal, occipital) on the left and right side and by comparing both sides.This allows for the detection of intracranial hemorrhages with a volume upwards of 3.5ml and to a depth of 2.5cm. However, little is known about the influence of other intracranial conditions that could confound the measurements of the Infrascanner (e.g. ischemic stroke, brain surgery, brain tumors,...).
Therefore, the investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine the positive and negative predictive value of the Infrascanner in these different settings.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 89 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Ziekenhuis Oost-Limburg is the lead sponsor of 69 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan
Device: Infrascanner
patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI
Device: Infrascanner
patients that have undergone brain surgery
Device: Infrascanner
patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan
Device: Infrascanner
patients with headache complaints and a normal CT-scan of the brain
Device: Infrascanner
patients with head trauma and a normal CT-scan of the brain
Device: Infrascanner
bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.
Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)
Time frame: 5 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Ziekenhuis Oost-Limburg