NCT04290416

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 28, 2020

Status Verified

November 1, 2019

Enrollment Period

5.8 years

First QC Date

December 18, 2019

Last Update Submit

February 27, 2020

Conditions

EpilepsyMemory

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Intracranial electroencephalogram (iEEG)

    14 days (patient in hospital for this length of time)

  • Behavioural response data

    14 days (patient in hospital for this length of time)

Study Arms (1)

Microwire electrodes

EXPERIMENTAL

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

Interventions

Microwire electrodesDIAGNOSTIC_TEST
Microwire electrodes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth UHB Hospital

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Simon Hanslmayr, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2019

First Posted

February 28, 2020

Study Start

February 4, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 28, 2020

Record last verified: 2019-11

Locations

GB(1)