Calculating brain shift during surgery
Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
This study is testing a new way to track changes in the brain during surgery to see if it can help doctors perform better and improve results for patients with brain tumors and other brain issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sklifosovsky Institute of Emergency Care Government |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05477680 on ClinicalTrials.gov |
What this trial studies
This study aims to calculate the magnitude and type of intraoperative brain shift, which can lead to navigation imprecision during brain surgeries. Surgeons will assess the location of the brain surface and various intracranial structures in real-time during surgery. The collected data will be compared postoperatively with lesion characteristics and patient outcomes to evaluate the possibility of predicting brain shift. The study seeks to improve surgical navigation and outcomes for patients undergoing procedures for brain tumors and other intracranial conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-100 with newly diagnosed intracranial tumors, cavernomas, arteriovenous malformations, or spontaneous and traumatic intracerebral hemorrhages.
Not a fit: Patients with rapid cerebral dislocation may not benefit from this study due to the nature of their condition.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of brain surgeries, leading to better patient outcomes and reduced complications.
How similar studies have performed: While there have been attempts to address intraoperative brain shift, this study's specific approach to calculating and predicting brain shift is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Moscow
- Sklifosovsky Institute of Emergency Care — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Alexander Dmitriev, MD — Sklifosovsky Institute of Emergency Care
- Study coordinator: Alexander Dmitriev, MD
- Email: dmitriev@neurosklif.ru
- Phone: +7 (916) 423-54-08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.