BRASH: Intraoperative Brain Shift Calculation Study

Sponsor

Sklifosovsky Institute of Emergency Care (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05477680

Collaborator

(none)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tumor, Brain Cavernoma Arteriovenous Malformations Intracerebral Hematoma	Device: Navigation-guided surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgery Removing different brain lesions using neuronavigation	Device: Navigation-guided surgery Surgeon removes brain lesions and assesses brain shift with neuronavigation

Arm

Intervention/Treatment

Experimental: Surgery

Removing different brain lesions using neuronavigation

Device: Navigation-guided surgery

Surgeon removes brain lesions and assesses brain shift with neuronavigation

Outcome Measures

Primary Outcome Measures

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