Intraoperative Brain Shift Calculation Study (BRASH)

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

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

Study Overview

• Status: Recruiting
• Conditions: Arteriovenous Malformations; Tumor, Brain; Cavernoma; Intracerebral Hematoma
• Intervention / Treatment: Device: Navigation-guided surgery

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Dmitriev, MD; Phone Number: +7 (916) 423-54-08; Email: dmitriev@neurosklif.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 129090
    • Recruiting
    • Sklifosovsky Institute of Emergency Care
    • Contact: Alexander Dmitriev, MD; Phone Number: +7 (916) 423-54-08; Email: dmitriev@neurosklif.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sklifosovsky Institute of Emergency Care
• Investigators: Principal Investigator: Alexander Dmitriev, MD, Sklifosovsky Institute of Emergency Care

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: tumor; arteriovenous malformation; cavernoma; intracerebral hematoma; brain shift
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Hemostatic Disorders; Central Nervous System Neoplasms; Nervous System Neoplasms; Cardiovascular Abnormalities; Hemangioma; Neoplasms, Vascular Tissue; Vascular Malformations; Intracranial Hemorrhages; Cavernous Sinus Syndromes; Congenital Abnormalities; Brain Neoplasms; Arteriovenous Malformations; Cerebral Hemorrhage; Hematoma; Hemangioma, Cavernous
• Other Study ID Numbers: 9e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No