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Neurostimulation Device
Depth Electrode Monitoring for Traumatic Brain Injury
N/A
Recruiting
Led By David Darrow, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient recommended to undergo EVD placement for the monitoring and possible treatment of Intracranial pressure (ICP) after TBI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether a new way of measuring and recording brain activity can help predict and treat a type of brain injury.
Who is the study for?
This trial is for patients who need a procedure called EVD placement to monitor and possibly treat high brain pressure after a traumatic brain injury. It's not for those with systemic infections, non-English speakers, uncorrectable blood clotting disorders, or contaminated scalp wounds.Check my eligibility
What is being tested?
The study is testing the use of depth electrodes to detect Cortical Spreading Depolarization (CSD), which are waves of brain activity that may occur after a traumatic brain injury and require neurosurgical intervention.See study design
What are the potential side effects?
While specific side effects aren't listed, depth electrode insertion can potentially cause discomfort at the site of implantation, risk of infection, bleeding in the brain, or seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am advised to have a procedure to monitor and possibly treat brain pressure after a brain injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Detecting CSDs in TBI patients
Trial Design
1Treatment groups
Experimental Treatment
Group I: FeasibilityExperimental Treatment1 Intervention
This is a preliminary, prospective interventional study to investigate the feasibility of using depth electrodes in conjunction with novel analytical algorithms to detect CSDs in TBI patients.
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,380 Previous Clinical Trials
1,588,730 Total Patients Enrolled
David Darrow, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a permanent blood clotting disorder.I do not speak English.I have a known infection in my body.I have a dirty cut on my head.I am advised to have a procedure to monitor and possibly treat brain pressure after a brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: Feasibility
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for individuals to enrol in this clinical exploration?
"As per the information available on clinicaltrials.gov, this research project is recruiting participants at present. The trial was initially listed on December 15th 2021 and recently modified on November 3rd 2022."
Answered by AI
What is the current enrollment size for this clinical trial?
"Yes, the information on clinicialtrials.gov suggests that this trial is recruiting individuals at present. The study was initially published on December 15th 2021 and most recently updated on November 3rd 2022. There are a total of 15 participants being accepted from one location."
Answered by AI
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