Electrical Impedance Tomography of Stroke and Brain Injury

November 30, 2023 updated by: University College, London

Imaging Stroke, Epilepsy and Evoked Potentials in the Brain Using Electrical Impedance Tomography

The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can produce reproducible and accurate images in people with stroke or head injury compared to existing standards such as MRI, CT.

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 stroke or head injury using rings of ECG like electrodes on the skin. EIT recording will take place as early as possible, usually within 24 hours of admission. Following completion of the recording, the EIT images will subsequently be analysed and compared to other imaging data for accuracy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Electrical Impedance Tomography (EIT) is a novel medical imaging method in which tomographic images are rapidly produced using electrodes placed around the body. The principal applicant's group has demonstrated that EIT can rapidly image functional brain activity in stroke, epilepsy and normal activity in animal models and has developed instrumentation and image reconstruction algorithms which work well in head-shaped tanks.

The principal aim of this research is to optimise and assess accuracy of Electrical Impedance Tomography (EIT) using scalp electrodes in imaging stroke/head injury in human participants. EIT could provide a unique new imaging modality which could provide continuous monitoring at the bedside after head injury or diagnosis in the back of an ambulance or GP surgery and so permit rapid deployment of thrombolytic therapy. If successful, EIT would become a standard imaging technique available in all ambulances and A&E departments for this purpose. It would be used in all cases of suspected stroke which present except to dedicated acute stroke centres. Imaging could be undertaken at presentation by paramedical staff if in an ambulance, or nurses or radiographers if in A&E. Images would be reported by radiologists remotely who could then sanction administration of thrombolytic agents by physicians, nurses or paramedical staff. EIT would allow neuroimaging to be undertaken significantly earlier in all situations where a dedicated stroke centre with available urgent CT was not available. This would benefit clinical staff who could provide an improved service and patients, who would enjoy improved outcome and greater access to thrombolytic therapy.

The recording will take place with scalp electrodes while the patient sits comfortably in a chair or lies on a bed. Recording takes for 10 minutes to 1 hour. In some subjects, EIT can be used to image changes in the brain over hours following head injury. In this case, recording will take place over hours or days with scalp electrodes according to the clinical situation. Stroke patients could also be recorded in this study, as similar changes in the injured brain could also occur after stroke. Following completion of the recording, scalp electrodes and any paste will be removed. Collected data will be analysed and compared to other imaging data.

Study Type

Observational

Enrollment (Estimated)

150

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
      • London, United Kingdom, NW1 2BU
        • Hyper-Acute Stroke Unit University College 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stroke patients or patients under hospital observation after a head injury at the University College Hospital

Description

Inclusion Criteria:

  • Patient with MRI or CT evidence of a stroke
  • Ability to give informed consent or have a consultee able to provide informed consent (for stroke group)
  • Any subject admitted for observation following a head injury (for head injury group)

Exclusion Criteria:

  • non (for stroke group)
  • Any skull fractures or other injury which precludes the safe application of scalp electrodes (for head injury group)

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stroke
Electrical Impedance Tomography with scalp electrodes
Device: Electrical Impedance Tomography
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.
Other Names:
  • EIT
Head Injury
Electrical Impedance Tomography with scalp electrodes
Device: Electrical Impedance Tomography
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.
Other Names:
  • EIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EIT images accuracy
Time Frame: three years
images accuracy defined by the image errors
three years

Collaborators and Investigators

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

Sponsor

University College, London

Collaborators

University College London Hospitals

Investigators

  • Principal Investigator: David S Holder, Professor, University College London, University College Hospital

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

October 1, 2015

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (Actual)

February 14, 2017

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/0861b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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