Your session is about to expire
← Back to Search
Device
24/7 EEG Monitoring for Temporal Lobe Epilepsy
N/A
Recruiting
Led By Michael Gelfand
Research Sponsored by UNEEG Medical A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Semiology of seizures compatible with temporal lobe involvement
Uncontrolled epileptic seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the 24/7 EEG SubQ system to the gold standard for epilepsy monitoring (video-EEG in the Epilepsy Monitoring Unit) and to self-reported seizure log books.
Who is the study for?
This trial is for adults aged 18-75 with temporal lobe epilepsy who have uncontrolled seizures and evidence of temporal seizure focus. They must be scheduled for clinical monitoring within 12 weeks post-implant, able to consent, and complete all study procedures. Excluded are those at high risk of surgical complications or on frequent medication like antiplatelets or NSAIDs.Check my eligibility
What is being tested?
The trial tests the 24/7 EEG™ SubQ system against standard video-EEG in a hospital setting and patient-reported seizure logs over a period of 12 weeks. It aims to assess safety and effectiveness in recording long-term EEG data for patients with temporal lobe epilepsy.See study design
What are the potential side effects?
Potential side effects may include risks associated with minor surgery needed to implant the device, such as infection, bleeding, or allergic reactions to materials used. There might also be discomfort or skin irritation around the implant site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My seizures are related to the temporal lobe of my brain.
Select...
I have seizures that my medication cannot control.
Select...
I am between 18 and 75 years old.
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
number of seizures
Secondary outcome measures
adverse event
Trial Design
1Treatment groups
Experimental Treatment
Group I: 24/7 EEG™ SubQ SystemExperimental Treatment1 Intervention
To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data.
Find a Location
Who is running the clinical trial?
UNEEG Medical A/SLead Sponsor
14 Previous Clinical Trials
198 Total Patients Enrolled
3 Trials studying Epilepsy
42 Patients Enrolled for Epilepsy
Michael GelfandPrincipal InvestigatorUniversity of Pennsylvania
Jay PathmanathanPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have bone damage or deformities where they plan to place the implant that could cause issues.My seizures are related to the temporal lobe of my brain.I have seizures that my medication cannot control.I am scheduled for a hospital stay to monitor my epilepsy within 3 months after getting a UNEEG™ SubQ implant.I am willing and able to sign a consent form.I can attend all required study visits and complete necessary tests.I frequently take medication like blood thinners, chemotherapy drugs, or anti-inflammatory drugs.My tests show seizures starting in the brain's temporal area.You have a cochlear implant.You have an active deep brain stimulation device.I have a health condition that increases my risk of surgery complications.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: 24/7 EEG™ SubQ System
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.
Does the enrollment criteria for this clinical trial encompass individuals under 30 years of age?
"This trial's eligibility requirements stipulate that participants must be 18 years or older yet not exceed 75."
Answered by AI
What is the capacity of this clinical trial for participants?
"Affirmative. According to the details posted on clinicaltrials.gov, enrollment for this research endeavor is still open; it was initially published on April 21st 2021 and was recently updated June 21st 2022. The investigators are looking to recruit 100 individuals between two distinct medical sites."
Answered by AI
Are there still slots available for potential participants in this experiment?
"Clinicaltrials.gov indicates that this research trial is currently accepting applicants, with the initial posting date being April 21st 2021 and a recent edit made on June 21st 2022."
Answered by AI
Who is eligible to take part in this research initiative?
"Patients wishing to join this scientific research must possess aura and be between 18 years old - 75. The desired sample size is 100 participants."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger