Intraoperative Brain Shift Calculation Study

NCT05477680 | Recruiting

• 1 other identifier: 9e
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tumor, Brain; Cavernoma; Arteriovenous Malformations; Intracerebral Hematoma

Keywords

brain shift; tumor; cavernoma; arteriovenous malformation; intracerebral hematoma

Outcome Measures

Primary Outcomes (1)

• Brain shift (in millimeters)

  Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location

  Intraoperatively

Secondary Outcomes (2)

• Karnofsky Performance status in percents

  within 10 days after surgery

• Cerebral complications

  From admission to intensive care unit after surgery till hospital discharge, up to 365 days

Study Arms (1)

Surgery

EXPERIMENTAL

Removing different brain lesions using neuronavigation

Device: Navigation-guided surgery

Interventions

Navigation-guided surgery DEVICE

Surgeon removes brain lesions and assesses brain shift with neuronavigation

Surgery

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• rapid cerebral dislocation

Sponsors & Collaborators

• Sklifosovsky Institute of Emergency Care: lead

Study Sites (1)

Sklifosovsky Institute of Emergency Care

Moscow, 129090, Russia

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Hemangioma, Capillary; Arteriovenous Malformations; Cerebral Hemorrhage; Neoplasms

Interventions

Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intracranial Hemorrhages; Cerebrovascular Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Alexander Dmitriev, MD

  Sklifosovsky Institute of Emergency Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Dmitriev, MD

CONTACT

+7 (916) 423-54-08; dmitriev@neurosklif.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)