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NCT Number: NCT05477680

Intraoperative Brain Shift Calculation Study

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navigation-guided surgery

Device

Surgeon removes brain lesions and assesses brain shift with neuronavigation

Primary outcomes

  1. Brain shift (in millimeters)

    Time frame: Intraoperatively

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

Secondary outcomes

  1. Karnofsky Performance status in percents

    Time frame: within 10 days after surgery

    Assesses patients' possibilities to self-service

  2. Cerebral complications

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

    Which cerebral complications arose after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Dmitriev, MD

CONTACT

[email protected]

+7 (916) 423-54-08

Sponsors and collaborators

Lead sponsor

Sklifosovsky Institute of Emergency Care

Other Gov

Registry information

Official study title

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

Acronym: BRASH

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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