Non-Invasive Low Pulsed Electrical Fields for Inducing BBB Disruption in Mice-Feasibility Demonstration.
Shirley Sharabi, David Last, Dianne Daniels...
https://pubmed.ncbi.nlm.nih.gov/33513968Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07224451
Liquid Biopsy Following Blood-Brain Barrier Disruption Using Barrier Disrupting Fields in Patients Undergoing Spine Surgery
Led by Sheba Medical Center · Updated on 2025-11-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with spinal tumors who are undergoing spine surgery to find new central nervous system (CNS) biomarkers. These biomarkers are measured in blood after temporarily opening the blood-arachnoid barrier using a technique called Barrier Disrupting Fields (BDF). This feasibility study aims to compare CNS biomarker levels in blood and cerebrospinal fluid (CSF) during surgery and monitor safety events related to the BDF procedure. Patients who need intradural tumor resection spinal surgery with intraoperative neuromonitoring will participate. During surgery, electrodes are attached to the patient's head after anesthesia, and blood samples are taken before and after the BDF procedure. The BDF uses low pulsed electric fields to transiently open the barrier protecting the brain. Surgery then continues as usual, with a CSF sample collected when the dura is opened to compare with blood biomarkers. Participants will be involved over about 24 months with assessments including blood and CSF sampling during surgery. Researchers will measure changes in blood CNS biomarker concentrations after BDF compared to CSF levels. Safety will be monitored by recording any adverse events related to BDF using standard grading criteria. The study seeks to advance blood-based methods for detecting brain proteins in patients undergoing spine surgery.
CONDITIONS
Brief Title
Liquid Biopsy Following BBB Disruption Using Barrier Disrupting Fields in Patients Undergoing Spine Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult subjects over the age of 18
- Able to sign informed consent
- Candidates for intradural tumor resection spinal surgery with intraoperative neuromonitoring
You will not qualify if you...
- Presence of pacemakers or other implanted electric medical devices
- Pregnant or lactating females
- Major medical, neurologic, or psychiatric conditions preventing compliance
- History of skull fractures or previous brain surgery
- American Society of Anesthesiologists grade greater than 2
- Current anticoagulant treatment
- Damage to the dura causing cerebrospinal fluid leak
- Patients with seizures or epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo spinal surgery with electrode placement on the head under anesthesia. Blood samples are taken before and after the barrier disrupting fields (BDF) procedure and before opening the dura. A cerebrospinal fluid (CSF) sample is taken at the time of dura opening. Surgery then continues as standard care.
1 surgical visit (in-person)
Trial Site Locations
Total: 1 location
1
Sheba Medical Center
Ramat Gan, Israel, 52621
Actively Recruiting
Loading map...
Research Team
Y
Yael Mardor, PhD
R
Ran Harel, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Transient blood-brain barrier disruption is induced by low pulsed electrical fields in vitro: an analysis of permeability and trans-endothelial electric resistivity.
Shirley Sharabi, Yael Bresler, Orly Ravid...
https://pubmed.ncbi.nlm.nih.gov/30957567