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Trial record 11 of 1443 for:    "Epilepsy" OR "pyridoxal 5'-phosphate-dependent epilepsy"

Electrical Impedance Tomography of Epilepsy

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ClinicalTrials.gov Identifier: NCT03050931
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment
Epilepsy Device: Electrical Impedance Tomography

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, intracranial electrode mats or deep electrodes in imaging epilepsy in human participants. If successful, EIT has the potential to provide a new portable imaging unit. It could be used with scalp electrodes and enable imaging of the onset and propagation of seizures in 3D. Image quality would be better with intracranial electrode mats or depth electrodes that are already implanted in people with severe epilepsy who are being evaluated for epilepsy surgery. For both electrode types, the new 3D information will enable better diagnosis and so targeting of drug treatment. It could also pave the way to suppression of seizures by deep brain electrical stimulation which could transform management in severe intractable epilepsy.It can offer the same benefits in imaging in epilepsy in neonates and infants.

Patients diagnosed with epilepsy will be asked to participate in the epilepsy EIT study, then up to 32 electrodes will be applied on the subjects' scalp or 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. It may also use some scalp EEG electrode placed on the scalp for clinical or research purposes. Following completion of the recording, scalp electrodes and any paste will be removed, the EIT system will be disconnected from the videoEEG. Collected data will be analysed and compared to other imaging data.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Imaging Stroke, Epilepsy and Evoked Potentials in the Brain Using Electrical Impedance Tomography
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Epilepsy with intracranial electrodes
Electrical Impedance Tomography with depth electrodes or intracranial electrode mats
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. 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.
Other Name: EIT

Epilepsy with scalp electrodes
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. 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.
Other Name: EIT




Primary Outcome Measures :
  1. EIT images accuracy [ Time Frame: three years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Epilepsy patients recruited from the patients of National Hospital for Neurology and Neurosurgery in London.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050931


Contacts
Contact: Anna M Witkowska-Wrobel, MD +44 02076790220 anna.witkowska-wrobel.14@ucl.ac.uk
Contact: Nir Goren, B.Sc. +44 02076790220 n.goren@ucl.ac.uk

Locations
United Kingdom
EEG telemetry unit Neurophysiology National Hospital for Neurology and Neurosurgery Recruiting
London, United Kingdom, WC1N 3BG
Contact: Beate Diehl, MD PhD    +44 020 3448 3287    beate.diehl@uclh.nhs.uk   
Contact: Tim Wehner, MD PhD    +44 020 3448 3287    tim.wehner@uclh.nhs.uk   
Sponsors and Collaborators
University College, London
University College London Hospitals
Investigators
Principal Investigator: David S Holder, Professor University College London, University College Hospital

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03050931     History of Changes
Other Study ID Numbers: 14/0861a
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017

Keywords provided by University College, London:
Electrical Impedance Tomography
EIT
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases