Electrical Impedance Tomography of Stroke and Brain Injury

NCT03052114 | Active Not Recruiting

• 1 other identifier: 14/0861b
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Craniocerebral Injuries

Keywords

Electrical Impedance Tomography; EIT; Stroke; Craniocerebral Injury; Head Injury

Outcome Measures

Primary Outcomes (1)

• EIT images accuracy

  images accuracy defined by the image errors

  three years

Study Arms (2)

Stroke

Electrical Impedance Tomography with scalp electrodes

Device: Electrical Impedance Tomography

Head Injury

Electrical Impedance Tomography with scalp electrodes

Device: Electrical Impedance Tomography

Interventions

Electrical Impedance Tomography DEVICE

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.

Also known as: EIT

Head Injury; Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator

Study Sites (1)

Hyper-Acute Stroke Unit University College Hospital

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Trauma, Nervous System; Wounds and Injuries

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 9, 2017
• First Posted: February 14, 2017
• Study Start: October 1, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

GB (1)