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Intraoperative Brain Shift Calculation Study

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05477680
Acronym
BRASH
Enrollment
100
Registered
2022-07-28
Start date
2022-09-01
Completion date
2027-08-31
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Malformations, Cavernoma, Intracerebral Hematoma, Tumor, Brain

Keywords

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

Brief summary

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

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.

Interventions

DEVICENavigation-guided surgery

Surgeon removes brain lesions and assesses brain shift with neuronavigation

Sponsors

Sklifosovsky Institute of Emergency Care
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Brain shift (in millimeters)IntraoperativelyMaximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location

Secondary

MeasureTime frameDescription
Karnofsky Performance status in percentswithin 10 days after surgeryAssesses patients' possibilities to self-service
Cerebral complicationsFrom admission to intensive care unit after surgery till hospital discharge, up to 365 daysWhich cerebral complications arose after surgery

Countries

Russia

Contacts

Primary ContactAlexander Dmitriev, MD
dmitriev@neurosklif.ru+7 (916) 423-54-08

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026