StrokeNCT03052114
Electrical Impedance Tomography of Stroke and Brain Injury
An observational study of Stroke and Craniocerebral Injuries, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Craniocerebral Injuries
- What is being tested?
- Electrical Impedance Tomography
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients or patients under hospital observation after a head injury at the University College Hospital
Who may be able to join
- 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)
Who cannot join
- non (for stroke group)
- Any skull fractures or other injury which precludes the safe application of scalp electrodes (for head injury group)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hyper-Acute Stroke Unit University College Hospital
London, NW1 2BU
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Craniocerebral Injuries
- Being tested
- Electrical Impedance Tomography
- Keywords
- Electrical Impedance Tomography, EIT, Stroke, Craniocerebral Injury, Head Injury
- Medical subject headings
- Stroke, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance TomographyDevice
Also called EIT
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Electrical Impedance Tomography with scalp electrodes Receives: Device: Electrical Impedance Tomography | |
| Head Injury | Electrical Impedance Tomography with scalp electrodes Receives: Device: Electrical Impedance Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
EIT images accuracy
images accuracy defined by the image errors
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startOct 2015
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- David S Holder, Professor, Principal investigator, University College London, University College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052114
- Sponsor's protocol ID
- 14/0861b
- Status last verified
- Mar 2025
- First submitted
- 9 Feb 2017
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Stroke, Epilepsy and Evoked Potentials in the Brain Using Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT03052114
- Acronym / sponsor ID
- 14/0861b
- Conditions
- Stroke, Craniocerebral Injuries
- Keywords
- Electrical Impedance Tomography, EIT, Stroke, Craniocerebral Injury, Head Injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- Oct 2015
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Device: Electrical Impedance TomographyElectrical Impedance Tomography with scalp electrodes |
| Head Injury | – | Device: Electrical Impedance TomographyElectrical Impedance Tomography with scalp electrodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients or patients under hospital observation after a head injury at the University College Hospital
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- non (for stroke group)
- Any skull fractures or other injury which precludes the safe application of scalp electrodes (for head injury group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Impedance TomographyAlso: EITEIT 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. | Device | Head Injury, Stroke |
Primary outcome
EIT images accuracy
Time frame: three years
images accuracy defined by the image errors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Holder, Professor principal investigator
University College London, University College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Craniocerebral Injuries, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EIT images accuracy (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.