Intraoperative Brain Shift Calculation Study

Study Overview
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Brief Summary
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The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

Detailed Description
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Brain shift is the main natural cause of major navigation imprecision. Despite numerous attempts no trials showed a possibility to calculate and predict it's value although some patterns were found. Some modern navigational features allow to partially resolve this problem. Manual shift correction allows to displace brain structures but can only be used if brain shift is linear. Intraoperative computed tomography (CT) and magnetic resonance imaging (MRI) allow to update navigational data but violate surgical workflow and cannot display brain tissue in real time. Intraoperative sonography has poorer quality, limited observe volume and lengthy learning curve. The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction. For each patient a surgeon intraoperatively will assess location of brain surface, various intracranial structures and lesion margins during surgery. Postoperatively these data will be compared to lesion's characteristics, patient's state and intraoperative features.

Official Title
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Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial

Conditions
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Tumor, Brain, Cavernoma, Arteriovenous Malformations, Intracerebral Hematoma

Intervention / Treatment
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* Device: Navigation-guided surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all intracranial tumors cavernomas arteriovenous malformations spontaneous (non-traumatic) intracerebral hemorrhages traumatic intracerebral hemorrhages supratentorial localization newly diagnosed age 18-100 years stable hemodynamics error of patient registration in neuronavigation no more than 2 mm Exclusion Criteria: rapid cerebral dislocation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br>Removing different brain lesions using neuronavigation | Device: Navigation-guided surgery<br>* Surgeon removes brain lesions and assesses brain shift with neuronavigation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain shift (in millimeters) | Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karnofsky Performance status in percents | Assesses patients' possibilities to self-service | within 10 days after surgery | 
| Cerebral complications | Which cerebral complications arose after surgery | From admission to intensive care unit after surgery till hospital discharge, up to 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain shift, tumor, cavernoma, arteriovenous malformation, intracerebral hematoma