search
Back to results

Human Single Neuron Recordings in Epilepsy Patients

Primary Purpose

Epilepsy, Memory

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Microwire electrodes
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Queen Elizabeth UHB Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microwire electrodes

Arm Description

Activity of individual neurons will be recorded via microwire contacts. These microwire electrodes do not interfere with the macrowire clinical recordings.

Outcomes

Primary Outcome Measures

Single unit recordings
Activity of individual neurons will be recorded via micro wire electrodes

Secondary Outcome Measures

Intracranial electroencephalogram (iEEG)
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)
Behavioural response data
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.

Full Information

First Posted
December 18, 2019
Last Updated
February 27, 2020
Sponsor
University of Birmingham
Collaborators
European Commission, Queen Elizabeth Hospital NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT04290416
Brief Title
Human Single Neuron Recordings in Epilepsy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 4, 2016 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
Collaborators
European Commission, Queen Elizabeth Hospital NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Memory

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microwire electrodes
Arm Type
Experimental
Arm Description
Activity of individual neurons will be recorded via microwire contacts. These microwire electrodes do not interfere with the macrowire clinical recordings.
Intervention Type
Diagnostic Test
Intervention Name(s)
Microwire electrodes
Primary Outcome Measure Information:
Title
Single unit recordings
Description
Activity of individual neurons will be recorded via micro wire electrodes
Time Frame
14 days (patient in hospital for this length of time)
Secondary Outcome Measure Information:
Title
Intracranial electroencephalogram (iEEG)
Description
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)
Time Frame
14 days (patient in hospital for this length of time)
Title
Behavioural response data
Description
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.
Time Frame
14 days (patient in hospital for this length of time)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Hanslmayr, PhD
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth UHB Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Human Single Neuron Recordings in Epilepsy Patients

We'll reach out to this number within 24 hrs