Intraoperative Brain Shift Calculation Study (BRASH)

Sklifosovsky Institute of Emergency Care

Status: Enrolling

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

Treatments: Device: Navigation-guided surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05477680

9e

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Surgery

Experimental group

Description:

Removing different brain lesions using neuronavigation

Treatment:

Device: Navigation-guided surgery