EpilepsyNCT01273129
Surgery as a Treatment for Medically Intractable Epilepsy
An observational study of Epilepsy and Epilepsy, Temporal Lobe, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for… Read more about this study
- Who is it for?
- Ages 8 to 99 years
- Conditions the study is for
- Epilepsy, Epilepsy, Temporal Lobe, Partial Epilepsy
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2011to not given
- 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 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients 8 years and older whose seizures are uncontrollable with medication may participate in this study as well as patients with tumor related epilepsy in whom invasive monitoring is indicated.
Who may be able to join
- To be eligible for entry into the study, candidates must:
- 1. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy.
Who cannot join
- Candidates will be excluded if they:
- 1. Are unable or unwilling to give informed consent, or have a parent able to provide informed consent if a minor, to the research procedures.
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. TTY dial 711, ccopr@nih.gov
About this study
Background:
- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in using the data collected as part of routine standard epilepsy care to better understand epilepsy and its treatment.
Read more
Objectives:
- To use surgery as a treatment for drug resistant epilepsy in children and adults.
Eligibility:
- Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy.
Design:
- Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study.
- Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach.
- Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period.
- Electrodes placed directly in the brain or on the surface of the brain to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus).
- Participants will have a surgical procedure at the site of their seizure focus. Brain lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality will be either removed or treated in a way that will stop or help prevent the spread of seizures without affecting irreplaceable brain functions, such as the ability to speak, understand, move, feel, or see.
- Participants will return for outpatient visits and brain imaging studies 2 months, 1 year, and 2 years after surgery.
Read the detailed description
Objective
This protocol is being performed to collect prospective data on patients who receive standard of care treatment for drug resistant epilepsy and to follow the natural history of patients receiving epilepsy surgery, to investigate neurophysiological correlates of human cognitive function, to provide invasive monitoring for patients with tumor related epilepsy. Any treatment under this protocol will be based on the current standard of care for epilepsy surgery.
Study Population
Patients 8 years and older whose seizures are uncontrollable with medication may participate in this study as well as patients with tumor related epilepsy in whom invasive monitoring is indicated.
Study Design
Patients will be screened by study neurologists to confirm their diagnosis of drug resistant epilepsy. Patients that do not have a confirmed diagnosis of drug resistant epilepsy will be offered further evaluation in protocol 18-N-0066, Investigating Epilepsy: Screening, Evaluation and Treatment. Patients confirmed to have drug resistant epilepsy will be offered standard invasive and non-invasive diagnostic and surgical procedures. Diagnostic invasive monitoring with intracranial electrodes for further localization of their seizure focus may be required. The ultimate goal is to surgically remove or modify the epileptic focus. Standard procedures to be performed are 1) anterior temporal lobectomy or 2) amygdalohippocampectomy for temporal lobe epilepsy, 3) focal cortical resection for epilepsy that arises outside the temporal lobe, 4) removal of brain lesions causing epilepsy, 5) multiple subpial transection, and 6) placement of neurostimulator devices. These procedures are all FDA approved standard of care for treatment of drug resistant epilepsy.
In patients in whom invasive monitoring is medically necessary, neurophysiologic activity during cognitive tasks will be captured from intracranial surface and depth electrodes. Analysis will focus on the role of neuronal firing and aggregate neural activity 1) during cognitive function, 2) in other states such as wakefulness and sleep, and 3) during periods of time surrounding seizure activity.
Drug Resistant Epilepsy
Patients with drug resistant epilepsy will be followed for three months after the surgical procedure and will receive standard neurological examinations and MRI evaluation of the brain. Participants in this protocol will be evaluated for potential eligibility for other NINDS clinical trials.
Tumor Related epilepsy
Patients with tumor related epilepsy will be enrolled in this protocol because of clinical indications arising from participation in a separate protocol, 16-N-0041 Tumor Related Epilepsy. Patients will complete participation after the three-month post-op visit.
Outcome Measures
By providing standard care treatment for patients with drug resistant epilepsy, this protocol allows for descriptive and/or correlational studies based on the data collected through clinical care of these patients including neurophysiological correlates of cognitive function and studies of tissue sample acquired during surgery. Outcomes for patients with tumor related epilepsy will be assessed under a separate protocol, 16-N-0041, Tumor Related Epilepsy.
- Conditions
- Epilepsy, Epilepsy, Temporal Lobe, Partial Epilepsy
- Keywords
- Neurosurgery, Childhood Epilepsy, Epilepsy, Frontal Lobe Epilepsy, Temporal Lobe Epilepsy, Natural History
- Medical subject headings
- Epilepsy, Epilepsy, Temporal Lobe, Epilepsies, Partial, Epilepsy, Frontal Lobe
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 |
|---|---|---|
| Patients | Patients 8 years and older whose seizures are uncontrollable with medication may participate in this study as well as patients with tumor related epilepsy in whom invasive monitoring is indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive and/or correlational studies
By providing standard care treatment for patients with drug resistant epilepsy, this protocol allows for descriptive and/or correlational studies based on the data collected through clinical care of these patients including neurophysiological correlates of cognitive function and studies of tissue sample acquired during surgery. Outcomes for patients with tumor related epilepsy will be assessed under a separate protocol, 16-N-0041, Tumor Related Epilepsy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study start21 Mar 2011
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 EpilepsyStudies 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
- 300 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
- Kareem A Zaghloul, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273129
- Sponsor's protocol ID
- 110051
- Other IDs
- 11-N-0051
- Status last verified
- 24 Sep 2026
- First submitted
- 7 Jan 2011
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do plan to share IPD. we will share all IPD that results in a publication on a public repository, as required by most journals. the data will be de-identified and anonymized.
Publications
Chittajallu R, Auville K, Mahadevan V, Lai M, Hunt S, Calvigioni D, Pelkey KA, Zaghloul KA, McBain CJ. Activity-dependent tuning of intrinsic excitability in mouse and human neurogliaform cells. Elife. 2020 Jun 4;9:e57571. doi: 10.7554/eLife.57571.
PubMed 32496194
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
- Surgery as a Treatment for Medically Intractable Epilepsy
- ClinicalTrials.gov ID
- NCT01273129
- Acronym / sponsor ID
- 110051
- Conditions
- Epilepsy, Epilepsy, Temporal Lobe, Partial Epilepsy
- Keywords
- Neurosurgery, Childhood Epilepsy, Epilepsy, Frontal Lobe Epilepsy, Temporal Lobe Epilepsy, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 21 Mar 2011 (actual)
- First posted
- 10 Jan 2011 (estimated)
- 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:
- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in using the data collected as part of routine standard epilepsy care to better understand epilepsy and its treatment.
Objectives:
- To use surgery as a treatment for drug resistant epilepsy in children and adults.
Eligibility:
- Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy.
Design:
- Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study.
- Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach.
- Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period.
- Electrodes placed directly in the brain or on the surface of the brain to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus).
- Participants will have a surgical procedure at the site of their seizure focus. Brain lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality will be either removed or treated in a way that will stop or help prevent the spread of seizures without affecting irreplaceable brain functions, such as the ability to speak, understand, move, feel, or see.
- Participants will return for outpatient visits and brain imaging studies 2 months, 1 year, and 2 years after surgery.
Detailed description
Objective
This protocol is being performed to collect prospective data on patients who receive standard of care treatment for drug resistant epilepsy and to follow the natural history of patients receiving epilepsy surgery, to investigate neurophysiological correlates of human cognitive function, to provide invasive monitoring for patients with tumor related epilepsy. Any treatment under this protocol will be based on the current standard of care for epilepsy surgery.
Study Population
Patients 8 years and older whose seizures are uncontrollable with medication may participate in this study as well as patients with tumor related epilepsy in whom invasive monitoring is indicated.
Study Design
Patients will be screened by study neurologists to confirm their diagnosis of drug resistant epilepsy. Patients that do not have a confirmed diagnosis of drug resistant epilepsy will be offered further evaluation in protocol 18-N-0066, Investigating Epilepsy: Screening, Evaluation and Treatment. Patients confirmed to have drug resistant epilepsy will be offered standard invasive and non-invasive diagnostic and surgical procedures. Diagnostic invasive monitoring with intracranial electrodes for further localization of their seizure focus may be required. The ultimate goal is to surgically remove or modify the epileptic focus. Standard procedures to be performed are 1) anterior temporal lobectomy or 2) amygdalohippocampectomy for temporal lobe epilepsy, 3) focal cortical resection for epilepsy that arises outside the temporal lobe, 4) removal of brain lesions causing epilepsy, 5) multiple subpial transection, and 6) placement of neurostimulator devices. These procedures are all FDA approved standard of care for treatment of drug resistant epilepsy.
In patients in whom invasive monitoring is medically necessary, neurophysiologic activity during cognitive tasks will be captured from intracranial surface and depth electrodes. Analysis will focus on the role of neuronal firing and aggregate neural activity 1) during cognitive function, 2) in other states such as wakefulness and sleep, and 3) during periods of time surrounding seizure activity.
Drug Resistant Epilepsy
Patients with drug resistant epilepsy will be followed for three months after the surgical procedure and will receive standard neurological examinations and MRI evaluation of the brain. Participants in this protocol will be evaluated for potential eligibility for other NINDS clinical trials.
Tumor Related epilepsy
Patients with tumor related epilepsy will be enrolled in this protocol because of clinical indications arising from participation in a separate protocol, 16-N-0041 Tumor Related Epilepsy. Patients will complete participation after the three-month post-op visit.
Outcome Measures
By providing standard care treatment for patients with drug resistant epilepsy, this protocol allows for descriptive and/or correlational studies based on the data collected through clinical care of these patients including neurophysiological correlates of cognitive function and studies of tissue sample acquired during surgery. Outcomes for patients with tumor related epilepsy will be assessed under a separate protocol, 16-N-0041, Tumor Related Epilepsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients 8 years and older whose seizures are uncontrollable with medication may participate in this study as well as patients with tumor related epilepsy in whom invasive monitoring is indicated. |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients 8 years and older whose seizures are uncontrollable with medication may participate in this study as well as patients with tumor related epilepsy in whom invasive monitoring is indicated.
Key inclusion criteria (2 listed)
- 1. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy.
Key exclusion criteria (2 listed)
- 1. Are unable or unwilling to give informed consent, or have a parent able to provide informed consent if a minor, to the research procedures.
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
Descriptive and/or correlational studies
Time frame: 1 year
By providing standard care treatment for patients with drug resistant epilepsy, this protocol allows for descriptive and/or correlational studies based on the data collected through clinical care of these patients including neurophysiological correlates of cognitive function and studies of tissue sample acquired during surgery. Outcomes for patients with tumor related epilepsy will be assessed under a separate protocol, 16-N-0041, Tumor Related Epilepsy.
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.
- Derived from this study: PubMed 32496194Chittajallu R, Auville K, Mahadevan V, Lai M, Hunt S, Calvigioni D, Pelkey KA, Zaghloul KA, McBain CJ. Activity-dependent tuning of intrinsic excitability in mouse and human neurogliaform cells. Elife. 2020 Jun 4;9:e57571. doi: 10.7554/eLife.57571.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We do plan to share IPD. we will share all IPD that results in a publication on a public repository, as required by most journals. the data will be de-identified and anonymized.
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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.
Kareem A Zaghloul, 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 Epilepsy and Epilepsy, Temporal Lobe, 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 2 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 Surgical Neurology Branch ((301) 496-2921, nindsdir-snbrecruiti@ninds.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive and/or correlational studies (time frame: 1 year). 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 NCT01273129, 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 26 Oct 2026.