Microelectrodes in Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microelectrodes
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- 18-65 year old
- male or female
- right or left handed
- IQ>70
- medically refractory focal epilepsy requiring intracranial EEG for pre-surgical evaluation deemed medically necessary
- no contraindications to intracranial electrode study
- able and willing to participate in research
Exclusion Criteria:
- does not meet the inclusion criteria
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microelectrodes
Arm Description
Patients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring.
Outcomes
Primary Outcome Measures
Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons.
With the occipito-temporal implantation approach of implantation of microelectrodes, feasibility will measured by the number of place responsive neurons that could be isolated.
Secondary Outcome Measures
How Precise the Frequencies (Alpha, Beta, Delta, Theta, Gamma, and High-gamma) of Neural Brain Activity Predict the Speed of the Participant at Performing the Cognitive Task (Accuracy Measured in Percentage).
Secondary objective is to investigate whether it is possible to predict the speed of which each participant is performing and navigating during the cognitive task via the intracranial spectral EEG changes (alpha, beta, delta, theta, gamma, and high-gamma) during these tasks. Accuracy of frequency band (brain waves) predicting speed during specific cognitive tasks is measured by how precisely the frequency band predicts navigational speed and is expressed as a percentage of correct prediction.
Full Information
NCT ID
NCT05200455
First Posted
January 7, 2022
Last Updated
August 15, 2022
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT05200455
Brief Title
Microelectrodes in Epilepsy
Official Title
Microelectrodes in Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2009 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test microelectrodes in intracranial monitoring to see if they will provide novel information on the epileptic potential of the implanted brain tissue. A secondary objective is to investigate the activity of single neurons during specific cognitive tasks.
Detailed Description
The standard-of-care for medically refractory epilepsy is resective brain surgery. In certain patients, precise localization of the epileptic focus is done using intracranial EEG (iEEG) recording. In this type of EEG recording, electrodes are placed on the brain surface or inserted into the brain through an opening in the skull. In addition to standard electrode recording, this study will use ultra thin microelectrodes. Microelectrodes are only several micrometers thick and are useful because they are able to record the activity of single neurons in isolation. Such recordings have tremendous clinical potential in epilepsy surgery and tremendous research potential in cognitive neuroscience.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microelectrodes
Arm Type
Experimental
Arm Description
Patients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring.
Intervention Type
Device
Intervention Name(s)
Microelectrodes
Intervention Description
Microelectrode implantation
Primary Outcome Measure Information:
Title
Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons.
Description
With the occipito-temporal implantation approach of implantation of microelectrodes, feasibility will measured by the number of place responsive neurons that could be isolated.
Time Frame
Evaluated for each patient during monitoring period of approximately 2 weeks
Secondary Outcome Measure Information:
Title
How Precise the Frequencies (Alpha, Beta, Delta, Theta, Gamma, and High-gamma) of Neural Brain Activity Predict the Speed of the Participant at Performing the Cognitive Task (Accuracy Measured in Percentage).
Description
Secondary objective is to investigate whether it is possible to predict the speed of which each participant is performing and navigating during the cognitive task via the intracranial spectral EEG changes (alpha, beta, delta, theta, gamma, and high-gamma) during these tasks. Accuracy of frequency band (brain waves) predicting speed during specific cognitive tasks is measured by how precisely the frequency band predicts navigational speed and is expressed as a percentage of correct prediction.
Time Frame
Evaluated for each patient during monitoring period of approximately 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 year old
male or female
right or left handed
IQ>70
medically refractory focal epilepsy requiring intracranial EEG for pre-surgical evaluation deemed medically necessary
no contraindications to intracranial electrode study
able and willing to participate in research
Exclusion Criteria:
does not meet the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara C Jobst, MD, PhD
Organizational Affiliation
Section Chief of Adult Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Microelectrodes in Epilepsy
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