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Surgery as a Treatment for Medically Intractable Epilepsy

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ClinicalTrials.gov Identifier: NCT01273129
Recruitment Status : Recruiting
First Posted : January 10, 2011
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

Background:

- Medically intractable 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 training more neurologists and neurosurgeons in epilepsy surgery and care in order to better understand epilepsy and its treatment.

Objectives:

- To use surgery as a treatment for medically intractable 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.
  • Wada test to evaluate speech, comprehension, and memory centers of the brain, using a contrast dye to study the blood vessels of the brain and a short-term anesthetic administration procedure to test the effects on areas of speech and memory.
  • Depth electrodes and/or brain surface electrodes 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.

Condition or disease Intervention/treatment Phase
Epilepsy Epilepsy, Temporal Lobe Partial Epilepsy Procedure: Surgical Treatment of drug resistantepilepsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgery as a Treatment for Medically Intractable Epilepsy
Actual Study Start Date : March 21, 2011
Estimated Primary Completion Date : March 1, 2028
Estimated Study Completion Date : March 1, 2028


Arm Intervention/treatment
Experimental: 1
Patients 8 years of age or older with drug resistant epilepsy or tumor related epilepsy
Procedure: Surgical Treatment of drug resistantepilepsy

Removal of mesial temporal sclerosis through anterior temporal lobectomy or selective amygdalohippocamp ectomy. Selective amygdalohippocamp ectomy removes the medial temporal lobe and leaves more of the surrounding normal brain than anterior temporal lobectomy.

A non-ablative surgical, vagus nerve stimulation, uses electrodes implanted within the left carotid sheath, is an example of neuromodulation being used to treat drug resistant seizures.





Primary Outcome Measures :
  1. Change in seizure frequency [ Time Frame: 1 year ]
    Change in seizure frequency, as measured by the Engel scale before and 1 year after treatment.Engel s classification:Class I: patients who were completely seizure free, had auras only, or had convulsions with drug withdrawal only;Class II: rare disabling seizures or nocturnal seizures only;Class III: worthwhile improvement (frequent seizures but fewer than previously);Class IV: no improvement (frequent seizures with unchanged frequency compared to before surgery).The Engel Class rating will be made while the patient is taking antiepileptic medication


Secondary Outcome Measures :
  1. Percentage of patients who are able to be completely withdrawn from anti-epileptic medication [ Time Frame: 2 Year ]
    The proportion of patients who are able to completely withdrawn from anti-epileptic medication (measured 2 years after surgery; subjects will remain on antiepileptic medications for one year after surgery, and may be withdrawn from antiepileptic medications during the second year after surgery).

  2. Percentage of patients who are seizure-free (Engel Class I) [ Time Frame: 1 Year ]
    The proportion of patients who are seizure-free (Engel Class I) one year after surgery.

  3. Mean Engel Class one year after surgery stratified by the type of surgical procedure [ Time Frame: 1 Year ]
    Mean Engel Class one year after surgery stratified by type of surgical procedure performed.

  4. Percentage of patients with permanent neurological side effectsfrom surgical treatment [ Time Frame: 1 Year ]
    Permanent neurological deficits, assessed one year after surgery.

  5. Neurophysiological correlates of cognitive function [ Time Frame: Baseline ]
    1. Differences in local field potential (LFP) oscillatory power in both intracranial EEG and microwire recordings among a) the awake resting state, b) during cognitive activity, c) immediately prior to and during seizure activity, and d) during sleep.2. Differences in measures of coherence and phase synchrony for LFP oscillations recorded from both intracranial EEG and microwire recordings amonga) the awake resting state,b) during cognitive activity,c) immediately prior to and during seizure activity, andd) during sleep.3. Differences in the event-related potential (ERP) recorded from both intracranial EEG and microwire recordings amonga) the awake resting state,b) during cognitive activity,c) immediately prior to and during seizure activity, andd) during sleep.4. Analysis of waveforms from individual microwires to identify action potentials reflective of single-unit activity and differences in firing rates for individual neurons

  6. 6. Neurophysiological correlates of human cognitive function and to provide invasive monitoring for patients with tumor related epilepsy [ Time Frame: Baseline and 1 year ]
    Outcomes for subjects with tumor related epilepsy will be assessed under a separate protocol, 16-N-0041, Tumor Related Epilepsy



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

To be eligible for entry into the study, candidates must meet all the following criteria:

  1. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy.
  2. Have focal onset seizures.
  3. Seizures must persist despite medical therapy (drug resistant epilepsy) or seizures must be associated with the presence of a brain tumor.
  4. Able to give informed consent, or have a parent able to provide informed consent if a child.
  5. Agree to undergo brain surgery if indicated to treat drug resistant epilepsy.

EXCLUSION CRITERIA:

Candidates will be excluded if they:

  1. Are pregnant (subjects of childbearing age will be tested with a urine pregnancy test and will have agreed to avoid being pregnant by practicing a reliable form of contraception or by abstinence from sexual intercourse while undergoing evaluation for epilepsy surgery and for 1 month after epilepsy surgery).
  2. Cannot have an MRI scan.
  3. Have a bleeding disorder that cannot be corrected before invasive testing or surgery, or other medical conditions which would make testing or surgery unsafe, such as lung or cardiac disease which would increase the risk of general anesthesia or severe immunodeficiency or systemic cancer not related to a brain lesion.

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): NCT01273129


Contacts
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Contact: Gretchen C Scott, R.N. Not Listed SNBrecruiting@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Kareem A Zaghloul, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT01273129    
Other Study ID Numbers: 110051
11-N-0051
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: January 4, 2021

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Neurosurgery
Childhood Epilepsy
Epilepsy
Frontal Lobe Epilepsy
Temporal Lobe Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Drug Resistant Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes