Human Single Neuron Recordings in Epilepsy Patients

February 27, 2020 updated by: University of Birmingham
This study uses single neuron recordings in pre-surgical epilepsy patients to uncover the neural mechanisms underlying memory formation and retrieval. A secondary aim is to improve diagnostic tools to identify epileptogenic tissue.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Queen Elizabeth UHB Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Interest in participation.
  • Temporal lobe epilepsy that is clinically being investigated with implantations of depth electrodes as part of the pre-surgical epilepsy monitoring.
  • Cognitive/language skills sufficient to follow experimental instruction and maintain focus on the experiment.

Exclusion Criteria:

  • Patient does not want to participate.
  • Extra-temporal epilepsy, or electrode implantation strategy that does not allow the use of micro-macrowire electrodes.
  • Cognitive/language skills insufficient to follow experimental instruction and maintain focus on the experiment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Microwire electrodes
Activity of individual neurons will be recorded via microwire contacts. These microwire electrodes do not interfere with the macrowire clinical recordings.
Diagnostic test: Microwire electrodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single unit recordings
Time Frame: 14 days (patient in hospital for this length of time)
Activity of individual neurons will be recorded via micro wire electrodes
14 days (patient in hospital for this length of time)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial electroencephalogram (iEEG)
Time Frame: 14 days (patient in hospital for this length of time)

Secondary outcome measures will be iEEG signals recorded with the macro electrodes, such as:

  • Event-related potentials
  • EEG power and phase of Theta oscillations
  • EEG power and phase of Alpha/Beta oscillations
  • EEG power and phase of Gamma oscillations
  • EEG power of High Frequency Oscillations (>80 Hz)
14 days (patient in hospital for this length of time)
Behavioural response data
Time Frame: 14 days (patient in hospital for this length of time)
Laptop button presses and corresponding response times will be recorded in MATLAB and presentation file formats. This is acquired at patient's bedside during hospital admission.
14 days (patient in hospital for this length of time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

European Commission
Queen Elizabeth Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Simon Hanslmayr, PhD, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 4, 2016

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

February 27, 2020

First Posted (ACTUAL)

February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_15-074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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