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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female patients between 10 and 64 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-14 days of neural activity collection
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand how the brain creates and executes programs of action on the fly, without prior rehearsal.
Who is the study for?
This trial is for male and female epilepsy patients aged between 10 and 64 who are having intracranial electrodes placed for their condition. Participants must be able to understand instructions and concentrate well enough to respond correctly during tasks.
What is being tested?
The study is examining how the brain responds when creating new behaviors on-the-spot, focusing on specific brain areas: medial temporal lobe (MTL) and ventral prefrontal cortex (vPFC). It involves novel tasks, virtual reality environments, and direct brain stimulation.
What are the potential side effects?
Since this research involves recording from the brain with implanted electrodes, potential side effects may include discomfort at electrode sites, infection risk, or other complications related to neurosurgical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10 and 64 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7-14 days of neural activity collection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-14 days of neural activity collection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Behavioral performance (Accuracy as fraction of correct responses)
Neurophysiological activity (single-neuron activity in spikes/second)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Neuropace RNS DeviceExperimental Treatment1 Intervention
Patients are implanted with RNS device to treat their seizure activity
Group II: Epilepsy Monitoring UnitExperimental Treatment1 Intervention
Patient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,290 Total Patients Enrolled
4 Trials studying Epilepsy
162 Patients Enrolled for Epilepsy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 10 and 64 years old.I struggle to concentrate and often get things wrong because of it.
Research Study Groups:
This trial has the following groups:- Group 1: Epilepsy Monitoring Unit
- Group 2: Neuropace RNS Device
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.
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