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Completed

NCT Number: NCT05200455

Microelectrodes in Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microelectrodes

Device

Microelectrode implantation

Primary outcomes

  1. Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons.

    Time frame: Evaluated for each patient during monitoring period of approximately 2 weeks

    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 outcomes

  1. 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).

    Time frame: Evaluated for each patient during monitoring period of approximately 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2022
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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