Microelectrodes in Epilepsy

NCT ID: NCT05200455

Last Updated: 2022-09-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-18

Study Completion Date

2021-05-18

Brief Summary

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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

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Microelectrodes

Patients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring.

Group Type EXPERIMENTAL

Microelectrodes

Intervention Type DEVICE

Microelectrode implantation

Interventions

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Microelectrodes

Microelectrode implantation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Barbara Jobst

Chair, Department of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara C Jobst, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Section Chief of Adult Neurology

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01NS074450-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00021993

Identifier Type: -

Identifier Source: org_study_id

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