SeizuresNCT03478852
Investigating Epilepsy: Screening and Evaluation
An observational study of Seizures and Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. Read more about this study
- Who is it for?
- Ages 8 to 110 years
- Conditions the study is for
- Seizures, Epilepsy, Epilepsy, Temporal Lobe
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 31 Jul 2037
- 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 8 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and Children age 8 years and older referred with a known or suspected diagnosis of epilepsy
Who may be able to join
- Age 8 years or older
- Known or suspected diagnosis of epilepsy
- Ability to give informed consent or have a legally authorized representative able to give consent (for adults without consent capacity) or parent/guardian able to provide informed consent (for a child)
- If unable to give informed consent, ability to give verbal assent
Who cannot join
- Patients with unstable medical conditions that, in the opinion of the investigators, makes participation unsafe, or who, in the opinion of the investigators may be unable to comply with the protocol
- Patients who are unable to travel to the NIH
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Background:
Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy.
Read more
Objectives:
To learn more about seizures and find ways to best treat people with drug-resistant epilepsy.
Eligibility:
Adults and children ages 8 years and older with diagnosed or suspected epilepsy
Design:
Participants will be screened with:
Physical exam
Medical history
Questionnaires
Participants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed.
Participants will have many tests:
Blood and urine tests
EEG: Wires attached to the head with paste record brain waves. This may be videotaped.
Thinking and memory tests
MRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube.
MEG: Participants lie on a table and place their head in a helmet to record brain waves.
PET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle.
Participants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.
Read the detailed description
Study Description:<TAB>
This protocol is designed to serve as a screening protocol that provides standard evaluation and treatment for patients with epilepsy. Clinical data collected through this protocol will be used in other NIH epilepsy-related research to screen for eligibility in the respective protocols and may also be used for descriptive and/or correlative research through this protocol.
Objectives:
Primary Objective:
Maintain a cohort of patients who are referred to the NIH with a known or suspected diagnosis of epilepsy that can be accessed by other NIH studies to screen for eligibility to participate in ongoing epilepsy-related protocols.
Secondary Objectives:
- to follow the natural history of subjects with epilepsy and epilepsy and related disorders, and
- to allow for descriptive and/or correlational studies based on the data collected through clinical care of these patients.
- Conditions
- Seizures, Epilepsy, Epilepsy, Temporal Lobe, Partial Epilepsy
- Keywords
- Seizure Disorder, Seizures, Antiepileptic Drug, Natural History Study, Screening Protocol
- Medical subject headings
- Seizures, Epilepsy, Epilepsy, Temporal Lobe, Epilepsies, Partial
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 |
|---|---|---|
| Single Arm | Single arm open enrollment of patients with standard of care treatment and evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols
to characterization of patients epilepsy to determine their eligibility for inclusion in other epilepsy-related protocols.
Measured: 5 year period
Secondary outcomes (1)
Data obtained through clinical care will provide descriptive and/or correlative research
data obtained through clinical care provided under this protocol in descriptive and/or correlative research in this and other protocols.
Measured: 5 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start28 Mar 2018
- Primary completion31 Jul 2037 (estimated)
- Study completion31 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Yasser Tajali, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478852
- Sponsor's protocol ID
- 180066
- Other IDs
- 18-N-0066
- Status last verified
- 21 Oct 2026
- First submitted
- 15 Mar 2018
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Epilepsy: Screening and Evaluation
- ClinicalTrials.gov ID
- NCT03478852
- Acronym / sponsor ID
- 180066
- Conditions
- Seizures, Epilepsy, Epilepsy, Temporal Lobe, Partial Epilepsy
- Keywords
- Seizure Disorder, Seizures, Antiepileptic Drug, Natural History Study, Screening Protocol
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 31 Jul 2037 (estimated)
- Study completion
- 31 Jul 2037 (estimated)
- First posted
- 27 Mar 2018 (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.
Background:
Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy.
Objectives:
To learn more about seizures and find ways to best treat people with drug-resistant epilepsy.
Eligibility:
Adults and children ages 8 years and older with diagnosed or suspected epilepsy
Design:
Participants will be screened with:
Physical exam
Medical history
Questionnaires
Participants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed.
Participants will have many tests:
Blood and urine tests
EEG: Wires attached to the head with paste record brain waves. This may be videotaped.
Thinking and memory tests
MRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube.
MEG: Participants lie on a table and place their head in a helmet to record brain waves.
PET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle.
Participants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.
Detailed description
Study Description:<TAB>
This protocol is designed to serve as a screening protocol that provides standard evaluation and treatment for patients with epilepsy. Clinical data collected through this protocol will be used in other NIH epilepsy-related research to screen for eligibility in the respective protocols and may also be used for descriptive and/or correlative research through this protocol.
Objectives:
Primary Objective:
Maintain a cohort of patients who are referred to the NIH with a known or suspected diagnosis of epilepsy that can be accessed by other NIH studies to screen for eligibility to participate in ongoing epilepsy-related protocols.
Secondary Objectives:
- to follow the natural history of subjects with epilepsy and epilepsy and related disorders, and
- to allow for descriptive and/or correlational studies based on the data collected through clinical care of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | –Single arm open enrollment of patients with standard of care treatment and evaluation |
Who may qualify
- Ages
- 8 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and Children age 8 years and older referred with a known or suspected diagnosis of epilepsy
Key inclusion criteria (4 listed)
- Age 8 years or older
- Known or suspected diagnosis of epilepsy
- Ability to give informed consent or have a legally authorized representative able to give consent (for adults without consent capacity) or parent/guardian able to provide informed consent (for a child)
- If unable to give informed consent, ability to give verbal assent
Key exclusion criteria (2 listed)
- Patients with unstable medical conditions that, in the opinion of the investigators, makes participation unsafe, or who, in the opinion of the investigators may be unable to comply with the protocol
- Patients who are unable to travel to the NIH
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
Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols
Time frame: 5 year period
to characterization of patients epilepsy to determine their eligibility for inclusion in other epilepsy-related protocols.
1 secondary outcome
Data obtained through clinical care will provide descriptive and/or correlative research
Time frame: 5 year period
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 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Yasser Tajali, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Seizures and Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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 States. 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 Aaliyah M HamidullahThiam ((301) 435-2952, aaliyah.hamidullahthiam@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols (time frame: 5 year period). 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 26 Oct 2026.