Intraoperative Brain Shift Calculation Study

Not Applicable

Recruiting

• Conditions: Arteriovenous Malformations; Cavernoma; Intracerebral Hematoma; Tumor, Brain
• Interventions: Device: Navigation-guided surgery

• Registration Number: NCT05477680
• Lead Sponsor: Sklifosovsky Institute of Emergency Care

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-28
• Study Start: 2022-09-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Navigation-guided surgery	Removing different brain lesions using neuronavigation

Primary Outcome Measures

Name	Time	Method
Brain shift (in millimeters)	Intraoperatively	Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sklifosovsky Institute of Emergency Care; 🇷🇺 Moscow, Russian Federation