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Brain Function Study for Epilepsy
N/A
Recruiting
Led By Krzysztof A Bujarski, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated for each patient during monitoring period of approximately 2 weeks.
Awards & highlights
Study Summary
This trial will enroll epilepsy patients who have electrodes in their brain or on their scalp, as well as normal and online controls. The aim is to study localization and function of the human brain using intracranial electrophysiology.
Who is the study for?
This trial is for adults with refractory epilepsy who are undergoing clinical intracranial EEG recording as part of their evaluation for epilepsy surgery. It also includes healthy individuals and online participants without epilepsy to serve as controls.Check my eligibility
What is being tested?
The study tests various aspects of human cognition in patients with electrodes implanted in the brain or on the scalp, using tasks related to memory, speech, emotions, etc., often involving computers and additional non-invasive monitoring equipment.See study design
What are the potential side effects?
Since this study involves cognitive testing and non-invasive monitoring rather than drug treatments, side effects may include discomfort from wearing monitoring devices or fatigue from participating in lengthy cognitive tasks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated for each patient during monitoring period of approximately 2 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated for each patient during monitoring period of approximately 2 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with attention and executive function.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with emotions.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with language.
+3 moreSecondary outcome measures
Measure the degree of correlation between the brain activation and cardiac physiology.
Measure the degree of correlation between the brain activation and sweat variations.
The degree of correlation between the brain activation and electrodermal activity.
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Scalp EEG (electrodes are placed on a participant's scalp)Experimental Treatment8 Interventions
Patients with non-invasive scalp electrodes who are admitted to the hospital for clinical reasons will be asked to participate in various study tasks with the recording of their EEG (recording of brain waves via electrodes attached to a participant's scalp) during these tasks.
Group II: Invasive EEG (electrodes are implanted in a participant's brain)Experimental Treatment9 Interventions
Patients with intracranial electrodes (electrodes are implanted in a participant's brain) undergoing pre-surgical evaluation for clinical reasons will be asked to participate in various study tasks with the recording of intracranial EEG (recording of brain waves via electrodes implanted in a participant's brain) during these tasks.
Group III: Normal ControlsActive Control7 Interventions
Normal controls will be recruited from family members of patients, from advertisements, or from online tools. There will be no EEG recordings obtained from these participants.
Group IV: Online ControlsActive Control7 Interventions
Certain control subjects will be recruited through Amazon Mechanical Turk. These participants will be given their task on the online platform using Qualtric survey function. The task design will be identical to normal controls who are recruited in-person, with the exception of identifiers. There will be no EEG recordings obtained from these participants.
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Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,164 Total Patients Enrolled
11 Trials studying Epilepsy
975 Patients Enrolled for Epilepsy
Dartmouth CollegeOTHER
79 Previous Clinical Trials
1,415,395 Total Patients Enrolled
Brown UniversityOTHER
456 Previous Clinical Trials
558,179 Total Patients Enrolled
3 Trials studying Epilepsy
299 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years or older and may need a scalp EEG.I am 18 years or older and may have an intracranial EEG.I am 18 years or older and do not have the condition being studied.I have hard-to-treat epilepsy and am undergoing special brain monitoring.I have an intracranial EEG but no other neurological or psychiatric conditions.My EEG results suggest I likely have epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: Normal Controls
- Group 2: Online Controls
- Group 3: Invasive EEG (electrodes are implanted in a participant's brain)
- Group 4: Scalp EEG (electrodes are placed on a participant's scalp)
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.
Are participants still able to join this experiment?
"According to the information found on clinicaltrials.gov, this trial is not open to recruitment at present time. The study was originally posted on November 15th 2022 and has since been updated last October 27th 2022; however, there are an abundance of other research studies actively seeking participants right now - with a total of 239 trials recruiting patients as we speak."
Answered by AI
What primary objectives are associated with this research endeavor?
"The primary purpose of this clinical trial is to quantify the alterations in electrical activity within the human brain pertaining to emotions. Additionally, investigators will assess the degree of correlation between brain activation and sweat production, respiratory action, as well as cardiac physiology over a two-week observation period. To record sweat amounts precisely, a Q-SWEAT system with four standardised compartments on areas such as foot dorsum and lower legs will be utilised. Moreover, respirations are monitored by noninvasive sensors around participants' chests and abdomens while heart rate variabilities are recorded using CNAP machines that take pressure measurements sans an arterial line or"
Answered by AI
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