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Neurostimulation with RNS System for Epilepsy (RESPONSE Trial)
RESPONSE Trial Summary
This trial will test whether a device that sends electrical pulses to the brain is safe and effective in treating people with epilepsy who haven't responded to other treatments.
RESPONSE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESPONSE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RESPONSE Trial Design
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Who is running the clinical trial?
Media Library
- You have a device in your brain that sends electrical energy.You have had medical tests that showed you have no more than two areas in your brain that can cause seizures.I or my caregiver can reliably count and describe my distinct seizures.I have been diagnosed with severe mental health issues like psychosis or major depression in the last year.I am on long-term blood thinners.My doctor thinks I can safely undergo a brain surgery.I have had a severe seizure without a clear cause in the last year.I have severe seizures that affect my daily life.I have tried at least two seizure medications without success.I can attend all required clinic appointments for the study.I have been diagnosed with seizures not caused by epilepsy.I am using a reliable method of birth control.I am between 12 and 17 years old, not yet 18.I have been diagnosed with generalized seizures.I've had 3 or more disabling seizures per month for the last 2 months.
- Group 1: Evaluation Group (stimulation ON)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants are being included in this clinical trial?
"This clinical trial necessitates 200 eligible individuals to participate. Westchester Medical Center in Hawthorne, New york and Spectrum Health System in Grand Rapids, Michigan are two registered sites where people can sign-up for the research."
To which population is admission to this trial restricted?
"This clinical trial seeks 200 individuals, aged 12-17, who suffer from aura and disabling motor simple partial seizures, complex partial seizures, or secondarily generalized seizures. To be eligible for the study, applicants must have no more than two epileptogenic regions; had an average of three or more disruptive episodes in each of the last consecutive 30 day periods; failed treatment with at least two anti-seizure medications; can maintain a diary electronically on their own or with assistance from a responsible individual; able to attend clinic appointments regularly; willing to provide informed consent/assent when required. Further still, those of childbearing potential need to"
In which medical centers is this research trial taking place?
"At this time, 6 different sites are running the clinical trial in question. These test centres are found in Hawthorne, Grand Rapids and Miami as well other nearby places. To minimize travel requirements if you decide to enroll, it is recommended that you select a site closest to your location of residence."
Are senior citizens eligible to participate in the clinical trial?
"According to the inclusion criteria, eligible participants of this trial must be aged between 12 and 17. The database displays 123 studies targeting minors while 201 target those aged 65 or above."
Is there a presently an opportunity to sign up for this experiment?
"As per the information provided on clinicaltrials.gov, this particular trial is still open for recruitment having been first announced on October 27th 2021 with a recent update made on November 11th 2022."
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