Single SeizureNCT05724719
Seizure Recurrence After Unprovoked First Seizure
An observational study of Single Seizure and Epilepsy, run by Dr. Gavin Winston at 2 sites in Canada.
Trial summary
One in 10 people have a seizure during their life. Usually no cause is identified. Seizures without an identified cause are called unprovoked first seizure (UFS). Most people with UFS do not have further seizures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Single Seizure, Epilepsy
- How many people
- 275 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Aug 2023to Sep 2026
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-65 years old with unprovoked first seizure; age, sex and education-matched healthy controls. Multi-centre, the study population will consist of adults from across Atlantic Canada, and South-Eastern Ontario.
Who may be able to join
- This study will consider adult patients between the ages of 18-65 years seen in the First Seizure Clinics in Halifax and Kingston with unprovoked first seizure.
- The investigators will also include a sample of age, sex, and education-matched healthy controls with the same exclusion criteria.
Who cannot join
- Individuals over the age of 65 will not be included to reduce the probability of including individuals with early dementia.
- The investigators will also exclude individuals who, upon assessment during their first clinic appointment, are determined to have non-epileptic events, recurrent events or diagnosis of epilepsy (e.g. based on abnormal CT or EEG), provoked seizure (e.g. medication, substance misuse, metabolic), acute symptomatic seizures, those with an existing prescription for antiseizure drugs, significant CNS comorbidity that may affect cognition and brain networks (e.g. progressive neurological disorder, MS), previous neurosurgery, or contraindication to MRI.
- Finally, although there is no known risk to a fetus from MRI scanning, as is standard in research studies involving MRI, pregnant participants will be excluded and those that suspect that they may be pregnant require a negative pregnancy test before scanning.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Dalhousie University and Nova Scotia Health Authority
Halifax, Nova Scotia
Isaac Cormier, BSc, 902-473-4263, isaac.cormier@nshealth.ca
Antonina Omisade, BA, PhD
- Recruiting
Queen's University and Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Christopher Hlynialuk, MSc, 613-533-6000 ext. 79750, hlynialuk.c@queensu.ca
Gavin P Winston, BM BCh, PhD
About this study
Official title: Multimodal Prediction of Seizure Recurrence After Unprovoked First Seizure to Guide Clinical Decision-making: a Multi-centre Study of Cognition, Mood and Brain Connectivity As Predictors
One in 10 people have a seizure during their life. Usually no cause is identified. Seizures without an identified cause are called unprovoked first seizure (UFS). Most people with UFS do not have further seizures. Being able to predict the risk of more seizures as soon as possible would help doctors decide whether to suggest treatment after UFS.
Studies show that seizures are associated with changes in brain structure and function that are difficult to detect with standard assessments but can be detected with advanced techniques. Changes in connections between brain regions are also linked to subtle problems in thinking and mood.
Read more
The investigators will examine brain connections using detailed brain scans, thinking, and mood in people with UFS and develop an accurate method for calculating the risk of further seizures.
200 adult patients and 75 matched healthy controls from the Halifax and Kingston First Seizure Clinics will undergo cognitive screening assessment of major cognitive domains, MRI imaging including structural scans, resting-state functional MRI (rsfMRI) and diffusion-weighted imaging (DWI), and EEG.
Seizure recurrence will be assessed prospectively and a multimodal machine learning model will be trained to predict seizure recurrence at 12 months.
- Conditions
- Single Seizure, Epilepsy
- Keywords
- Cognition, Mood, Brain Connectivity, Neuroimaging, Neurophysiology
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unprovoked First Seizure (UFS) | Participants will undergo cognitive screening assessment, MRI imaging and EEG (if not already done) within 2-4 weeks of the initial First seizure clinic visit. Seizure recurrence will be monitored by a diary provided to each participant with details of the research team to contact in the event of a seizure. A researcher via perform telephone reminders at 3, 6, 9 and 12 months following the seizure. The primary outcome will be seizure recurrence at 12 months. | |
| Healthy Controls | Healthy control participants will complete the same neuropsychological battery, MRI scans and EEG protocols to evaluate baseline level of impairment in a healthy population and for the group comparisons of UFS to healthy controls to establish the changes already present at initial presentation with UFS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Seizure Recurrence after Unprovoked First Seizure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Aug 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Single SeizureStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gavin Winston
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Dr. Gavin Winston, Queen's University
- Investigators
- Gavin P Winston, BM BCh, PhD, Principal investigator, Queen's UniversityAntonina Omisade, BA, PhD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724719
- Sponsor's protocol ID
- DMED-2681-22
- Other IDs
- PJT-183906
- Status last verified
- Oct 2024
- First submitted
- 1 Feb 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Beattie BC, Batista Garcia-Ramo K, Biggs K, Boisse Lomax L, Brien DC, Gallivan JP, Ikeda K, Schmidt M, Shukla G, Whatley B, Woodroffe S, Omisade A, Winston GP. Literature review and protocol for a prospective multicentre cohort study on multimodal prediction of seizure recurrence after unprovoked first seizure. BMJ Open. 2024 Apr 5;14(4):e086153. doi: 10.1136/bmjopen-2024-086153.
PubMed 38582538
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Prediction of Seizure Recurrence After Unprovoked First Seizure to Guide Clinical Decision-making: a Multi-centre Study of Cognition, Mood and Brain Connectivity As Predictors
- ClinicalTrials.gov ID
- NCT05724719
- Acronym / sponsor ID
- DMED-2681-22
- Conditions
- Single Seizure, Epilepsy
- Keywords
- Cognition, Mood, Brain Connectivity, Neuroimaging, Neurophysiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Dr. Gavin WinstonUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Nova Scotia Health Authority
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Feb 2023 (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.
One in 10 people have a seizure during their life. Usually no cause is identified. Seizures without an identified cause are called unprovoked first seizure (UFS). Most people with UFS do not have further seizures. Being able to predict the risk of more seizures as soon as possible would help doctors decide whether to suggest treatment after UFS.
Studies show that seizures are associated with changes in brain structure and function that are difficult to detect with standard assessments but can be detected with advanced techniques. Changes in connections between brain regions are also linked to subtle problems in thinking and mood.
The investigators will examine brain connections using detailed brain scans, thinking, and mood in people with UFS and develop an accurate method for calculating the risk of further seizures.
200 adult patients and 75 matched healthy controls from the Halifax and Kingston First Seizure Clinics will undergo cognitive screening assessment of major cognitive domains, MRI imaging including structural scans, resting-state functional MRI (rsfMRI) and diffusion-weighted imaging (DWI), and EEG.
Seizure recurrence will be assessed prospectively and a multimodal machine learning model will be trained to predict seizure recurrence at 12 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unprovoked First Seizure (UFS) | – | –Participants will undergo cognitive screening assessment, MRI imaging and EEG (if not already done) within 2-4 weeks of the initial First seizure clinic visit. Seizure recurrence will be monitored by a diary provided to each participant with details of the research team to contact in the event of a seizure. A researcher via perform telephone reminders at 3, 6, 9 and 12 months following the seizure. The primary outcome will be seizure recurrence at 12 months. |
| Healthy Controls | – | –Healthy control participants will complete the same neuropsychological battery, MRI scans and EEG protocols to evaluate baseline level of impairment in a healthy population and for the group comparisons of UFS to healthy controls to establish the changes already present at initial presentation with UFS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 years old with unprovoked first seizure; age, sex and education-matched healthy controls. Multi-centre, the study population will consist of adults from across Atlantic Canada, and South-Eastern Ontario.
Key inclusion criteria (2 listed)
- This study will consider adult patients between the ages of 18-65 years seen in the First Seizure Clinics in Halifax and Kingston with unprovoked first seizure.
- The investigators will also include a sample of age, sex, and education-matched healthy controls with the same exclusion criteria.
Key exclusion criteria (3 listed)
- Individuals over the age of 65 will not be included to reduce the probability of including individuals with early dementia.
- The investigators will also exclude individuals who, upon assessment during their first clinic appointment, are determined to have non-epileptic events, recurrent events or diagnosis of epilepsy (e.g. based on abnormal CT or EEG), provoked seizure (e.g. medication, substance misuse, metabolic), acute symptomatic seizures, those with an existing prescription for antiseizure drugs, significant CNS comorbidity that may affect cognition and brain networks (e.g. progressive neurological disorder, MS), previous neurosurgery, or contraindication to MRI.
- Finally, although there is no known risk to a fetus from MRI scanning, as is standard in research studies involving MRI, pregnant participants will be excluded and those that suspect that they may be pregnant require a negative pregnancy test before scanning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Seizure Recurrence after Unprovoked First Seizure
Time frame: 12 months
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 17 Oct 2024.
- Derived from this study: PubMed 38582538Beattie BC, Batista Garcia-Ramo K, Biggs K, Boisse Lomax L, Brien DC, Gallivan JP, Ikeda K, Schmidt M, Shukla G, Whatley B, Woodroffe S, Omisade A, Winston GP. Literature review and protocol for a prospective multicentre cohort study on multimodal prediction of seizure recurrence after unprovoked first seizure. BMJ Open. 2024 Apr 5;14(4):e086153. doi: 10.1136/bmjopen-2024-086153.
- Individual participant dataSharing planned: No
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.
Gavin P Winston, BM BCh, PhD principal investigator
Queen's University
Antonina Omisade, BA, PhD principal investigator
Nova Scotia Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Seizure and Epilepsy, run by Dr. Gavin Winston at 2 sites in Canada.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Contact Christopher Hlynialuk, MSc (613-533-6000 ext. 79750, hlynialuk.c@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Seizure Recurrence after Unprovoked First Seizure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05724719, which also lists 1 linked publication.
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 17 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.