NCT03050931

Brief Summary

The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can produce reproducible and accurate images in people with epilepsy compared to existing standards such as MRI, CT or EEG. Electrical Impedance Tomography is a relatively new medical imaging method, which has the potential to provide novel images of brain function. It is fast, portable, safe and inexpensive, but currently has a relatively poor spatial resolution. It produces images of the internal electrical impedance of a subject with epilepsy using rings of ECG like electrodes on the skin, intracranial electrode mats or deep electrodes implemented surgically as part of clinical assessment. EIT recording will take place in parallel with the routine recording on the ward. Following completion of the recording, the EIT images will subsequently be analysed and compared to other imaging data for accuracy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
May 2017Dec 2027

First Submitted

Initial submission to the registry

February 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

10.5 years

First QC Date

February 8, 2017

Last Update Submit

December 5, 2024

Conditions

Keywords

Electrical Impedance TomographyEITEpilepsy

Outcome Measures

Primary Outcomes (1)

  • EIT images accuracy

    three years

Study Arms (2)

Epilepsy with intracranial electrodes

Electrical Impedance Tomography with depth electrodes or intracranial electrode mats

Device: Electrical Impedance Tomography

Epilepsy with scalp electrodes

Electrical Impedance Tomography with scalp electrodes

Device: Electrical Impedance Tomography

Interventions

EIT comprises of a box of electronics similar in size to a video recorder, laptop computer and leads which link typically to 16 or 32 external ECG-like electrodes placed around the subject. Images are generated by applying tiny electrical signals through some electrodes and recording the resulting signals at others. The signals applied are completely safe, within established British and EU safety limits and cannot be felt. For intracranial electrode studies, the EIT systems will be linked to the existing EEG video recording systems and EIT will be recorded at the same time using some or all of the available intracranial electrodes.

Also known as: EIT
Epilepsy with intracranial electrodesEpilepsy with scalp electrodes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Epilepsy patients recruited from the patients of National Hospital for Neurology and Neurosurgery in London.

You may qualify if:

  • Any patient with epilepsy with either active seizures or interictal EEG changes (for scalp electrodes group)
  • Any patient with epilepsy with either active seizures under evaluation for epilepsy surgery (for intracranial electrodes group)
  • Ability to give informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EEG telemetry unit Neurophysiology National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • David S Holder, Professor

    University College London, University College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 13, 2017

Study Start

May 30, 2017

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations