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Brain Stimulation
Brain Stimulation for Epilepsy and Memory Control
N/A
Waitlist Available
Led By Flavio Frohlich, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of medically intractable epilepsy
Be older than 18 years old
Must not have
Current diagnosis of other neurological illnesses including ischemic stroke, intracerebral hemorrhage, brain neoplasm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 1- to 1.5-hour test at baseline and stimulation session conducted over a 1 to 2 day period
Summary
This trial aims to understand how brain waves affect memory control. The study will involve patients with epilepsy who had electrodes implanted previously. A total of 50 participants will take part in the study. They will
Who is the study for?
This trial is for patients with medically intractable epilepsy who have had electrodes implanted for monitoring. They must be able to consent, speak English, and not have other major neurological illnesses, severe cognitive or psychiatric conditions, substance abuse issues, or any risk factors that could affect their participation as judged by the investigator.
What is being tested?
The study tests how different types of brain stimulation (theta and alpha oscillations) affect working memory control. Participants will undergo direct cortical stimulation while performing a cognitive task to see which stimulation methods best modulate brain activity.
What are the potential side effects?
While specific side effects are not listed here, direct cortical stimulation can potentially cause discomfort at the electrode site, headaches, seizures during the procedure (in those predisposed), and transient changes in mood or cognition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have epilepsy that doesn't respond to treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any other brain-related illnesses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the 1- to 1.5-hour test at baseline and stimulation session conducted over a 1 to 2 day period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 1- to 1.5-hour test at baseline and stimulation session conducted over a 1 to 2 day period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Working Memory Task Performance - Pashler's working memory capacity metric (k)
Change in Working Memory Task Performance - Reaction Time
Intracranial EEG Multi-taper fft
+1 moreSecondary study objectives
Intracranial EEG Granger causality
Intracranial EEG Wavelets
Intracranial EEG phase locking
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Frontal StimulationActive Control3 Interventions
Direct Cortical Stimulation (DCS) in alpha and theta frequencies is applied through electrodes located in the frontal cortex.
Group II: Frontal Parietal StimulationPlacebo Group3 Interventions
Direct Cortical Stimulation (DCS) in in-phase and anti-phase theta frequencies is applied through electrodes located in the frontal and parietal cortex.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,561 Previous Clinical Trials
4,298,691 Total Patients Enrolled
3 Trials studying Epilepsy
30,040 Patients Enrolled for Epilepsy
National Institute of Mental Health (NIMH)NIH
2,928 Previous Clinical Trials
2,744,969 Total Patients Enrolled
10 Trials studying Epilepsy
5,356 Patients Enrolled for Epilepsy
Flavio Frohlich, PhDPrincipal InvestigatorUNC Chapel Hill
19 Previous Clinical Trials
539 Total Patients Enrolled
1 Trials studying Epilepsy
30 Patients Enrolled for Epilepsy