Human Single Neuron Recordings in Epilepsy Patients

Epilepsy Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04290416
• Other study ID #: RG_15-074
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 4, 2016
• Est. completion date: December 2021

Study information

• Verified date: November 2019
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Memory

Intervention

Diagnostic Test:
• Microwire electrodes

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth UHB Hospital	Birmingham	West Midlands

Sponsors (3)

Lead Sponsor	Collaborator
University of Birmingham	European Commission, Queen Elizabeth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single unit recordings	Activity of individual neurons will be recorded via micro wire electrodes	14 days (patient in hospital for this length of time)
Secondary	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)	14 days (patient in hospital for this length of time)
Secondary	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.	14 days (patient in hospital for this length of time)