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EEG-fMRI: Towards a Useful Clinical Tool in Epilepsy

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ClinicalTrials.gov Identifier: NCT02410889
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : October 12, 2016
Sponsor:
Collaborators:
University Hospital Birmingham
Birmingham and Solihull Mental Health NHS Foundation Trust
Information provided by (Responsible Party):
University of Birmingham

Brief Summary:
The purpose of this project is to develop the method of combined recording of electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) in order to improve understanding of the relationship between electrical (EEG) and blood flow (fMRI) responses to epileptic discharges as a necessary step towards clinical use. One factor that currently limits the use of EEG−fMRI in patients with epilepsy is that a relatively large proportion of patients do not show any fMRI response despite epileptic activity having been detected on the EEG recorded during scanning. The reasons for this are unclear, which makes it difficult to predict in advance whether useful information will be gained from the scanning session. What is it about some epileptic discharges that results in a detectable change in the fMRI signal, while others which are no less obvious or frequent do not? This question will be addressed by determining the factors that are responsible for the occurrence of robust fMRI signal changes via detailed morphological, topographical and spectral analysis of the EEG signal on an event by event basis.

Condition or disease Intervention/treatment
Epilepsy Other: EEG-fMRI scanning

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Only
Official Title: EEG-fMRI: Towards a Useful Clinical Tool in Epilepsy
Study Start Date : January 2007
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Patients with Epilepsy
A group of patients with a variety of types of epilepsy.
Other: EEG-fMRI scanning
Patients undergo EEG-fMRI scanning




Primary Outcome Measures :
  1. EEG and fMRI concordance [ Time Frame: Day 1 ]
    Assessment of the concordance between haemodynamic (fMRI) and electrical (EEG) measures of the brain response to epileptic discharges, both in terms of signal properties and localisation


Secondary Outcome Measures :
  1. EEG-fMRI clinical concordance [ Time Frame: Day 1 ]
    Assessment of the relationship between EEG−fMRI results and clinical data related to the type of epilepsy.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with epilepsy with interictal epileptic discharges evident on scalp EEG.
Criteria

Inclusion Criteria:

  1. adults with no contraindications to MRI scanning. Initial screening for MR compatibility will be performed at recruitment.
  2. epilepsy with interictal epileptic discharges evident on scalp EEG.
  3. rarity or lack of seizures. This is an important point to minimise the risk of the patient having a seizure during scanning.
  4. expected rate of interictal epileptic discharges sufficient to allow at least 10 but less than 200 events to be recorded per hour. Both too few and too many events make interpretation of the EEG−fMRI results difficult.
  5. willingness to remain in the scanner for a minimum of 40 minutes. This ensures that a reasonable amount of fMRI data is collected. It is important that motivated subjects are recruited, preferably those who have previously undergone MRI scanning and so have some idea of the environment.

Exclusion Criteria:

  1. contraindications to MRI scanning.
  2. epilepsy with rare or absent interictal discharges, or frequent seizures.
  3. patient is unable to give informed consent or understand the nature of the study.
  4. neurological or psychiatric diagnosis other than epilepsy.

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): NCT02410889


Locations
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United Kingdom
University of Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TT
Sponsors and Collaborators
University of Birmingham
University Hospital Birmingham
Birmingham and Solihull Mental Health NHS Foundation Trust

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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02410889     History of Changes
Other Study ID Numbers: RG_06-167
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: April 2015
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases