Intraoperative Brain Shift Calculation Study

Arteriovenous Malformations Clinical Trial

— BRASH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477680
• Other study ID #: 9e
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: April 2024
• Source: Sklifosovsky Institute of Emergency Care
• Contact: Alexander Dmitriev, MD
• Phone: +7 (916) 423-54-08
• Email: dmitriev[@]neurosklif.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Brain Neoplasms
• Cavernoma
• Cerebral Hemorrhage
• Congenital Abnormalities
• Hematoma
• Intracerebral Hematoma
• Tumor, Brain

Intervention

Device:
• Navigation-guided surgery
Surgeon removes brain lesions and assesses brain shift with neuronavigation

Locations

Country	Name	City	State
Russian Federation	Sklifosovsky Institute of Emergency Care	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Sklifosovsky Institute of Emergency Care

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain shift (in millimeters)	Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location	Intraoperatively
Secondary	Karnofsky Performance status in percents	Assesses patients' possibilities to self-service	within 10 days after surgery
Secondary	Cerebral complications	Which cerebral complications arose after surgery	From admission to intensive care unit after surgery till hospital discharge, up to 365 days