Actively Recruiting
Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
Led by Sklifosovsky Institute of Emergency Care · Updated on 2025-05-16
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the magnitude and type of brain shift that occurs during surgery to the brain and whether its movement can be predicted. Brain shift causes inaccuracy in surgical navigation despite many attempts to calculate and forecast it. The study focuses on patients undergoing surgery for various brain lesions, aiming to better understand this shift and improve navigation accuracy. Participants will undergo navigation-guided surgery where surgeons remove brain lesions and assess brain shift during the operation. The study uses neuronavigation to evaluate the brain's surface and internal structures in real time. Although other imaging methods exist, they either disrupt surgery or lack real-time brain tissue visualization. This study specifically assesses brain shift during surgery and compares it with lesion characteristics and patient status after surgery. During the study, surgeons will record brain structure locations intraoperatively. After surgery, researchers will compare these findings with postoperative data including performance status and brain complications. The main measurement is brain shift in millimeters during surgery. Additional monitoring includes assessing patient recovery status and cerebral complications up to one year after surgery. The total participation period varies based on surgery and follow-up assessments.
CONDITIONS
Brief Title
Intraoperative Brain Shift Calculation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with all intracranial tumors
- Patients with cavernomas
- Patients with arteriovenous malformations
- Patients with spontaneous (non-traumatic) intracerebral hemorrhages
- Patients with traumatic intracerebral hemorrhages
- Lesions located in the supratentorial region
- Newly diagnosed brain lesions
- Age between 18 and 100 years
- Stable hemodynamics
- Patient registration error in neuronavigation no more than 2 millimeters
You will not qualify if you...
- Rapid cerebral dislocation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the day of surgery and immediate recovery
Participants undergo navigation-guided surgery to remove brain lesions during which brain shift is assessed intraoperatively.
1 surgery visit (in-person)
Duration - Up to 365 days after surgery
Participants are monitored for cerebral complications and recovery, including assessment of Karnofsky Performance status within 10 days after surgery and ongoing observation up to hospital discharge and up to 365 days for complications.
Approximately 6 to 12 follow-up visits depending on recovery and hospital stay
Trial Site Locations
Total: 1 location
1
Sklifosovsky Institute of Emergency Care
Moscow, Russia, 129090
Actively Recruiting
Research Team
A
Alexander Dmitriev, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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