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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 below
Select...
I am advised to have a procedure to monitor and possibly treat brain pressure after a brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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

Depth electrodes (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05205174 — N/A
Traumatic Brain Injury Research Study Groups: Feasibility
Traumatic Brain Injury Clinical Trial 2023: Depth electrodes Highlights & Side Effects. Trial Name: NCT05205174 — N/A
Depth electrodes (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05205174 — N/A

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
~8 spots leftby Dec 2026