Research leads the way in finding a cure for epilepsy.
People with epilepsy have the option of taking part in clinical trials being conducted at Keck Medicine and elsewhere. While clinical trial participation does not ensure that an effective treatment will be received, participation does help provide invaluable information for future treatments.
Keck School of Medicine of USC faculty members lead and participate in many of the nation’s largest multi-center clinical trials, as well as in many unique smaller trials. Although participating in a clinical trial is not the right choice for everyone, many patients receiving care in one of USC’s affiliated medical facilities have chosen to become involved in clinical trials.
RNS® System LTT Study
The RNS® System LTT study is designed to assess the ongoing safety and to evaluate the
long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of
seizures in individuals 18 years of age or older with partial onset seizures that are
refractory to two or more antiepileptic medications. Candidates will continue to receive
their epilepsy medications while participating in the trial.
1. Subject has completed either the RNS® System Pivotal or Feasibility study
2. Subject has an implanted RNS® System
3. Subject has elected to continue to receive responsive neurostimulation therapy after
completion of the RNS® System Pivotal or Feasibility study
4. Subject is able to attend scheduled appointments for the RNS® System LTT study
1. Subject has active psychiatric or medical illness that makes it inadvisable for the
subject to continue to receive responsive neurostimulation therapy with the RNS®
2. Subject has been diagnosed with psychogenic or non-epileptic seizures, or primarily
generalized seizures during the RNS® System Pivotal or Feasibility study
3. Subject has been noncompliant with scheduled appointments during the RNS® System
Pivotal or Feasibility study
4. Subject has been noncompliant with maintaining seizure diaries during the RNS® System
Pivotal or Feasibility study
5. Informed consent cannot be obtained from subject or caregiver
Radiosurgery or Open Surgery for Epilepsy Trial
This study will compare radiosurgery (focused radiation, Gamma Knife Radiosurgery) with
temporal lobectomy (standard surgical care) as a treatment of temporal lobe epilepsy.
Patients who have seizures that begin in their temporal lobe that are not controlled with
medications into the trial will be offered entry. Patients with a high likelihood of having
their seizures controlled with open surgery will have treatment randomized between the
standard surgery and radiosurgery. A prior study has shown that focused radiation
(radiosurgery) may also reduce or eliminate seizures arising from the temporal lobe. The main
study hypothesis is that radiosurgery is as safe and effective as temporal lobectomy in
treating patients with seizures arising from the medial temporal lobe.
Inclusion and Exclusion Criteria:
Adults (18 years and older) of either gender who would otherwise be eligible for temporal
lobe resection will be offered enrollment for randomization to RS or ATL.
1. Seizure type: Patients must have simple and/or complex partial seizures with or
without secondary generalization.
2. Seizure Frequency: Patients must have at least 3 complex partial seizures during the 3
month (12 week) baseline seizure diary period with at least 1 of 3 seizures occurring
within the last 2 months (8 weeks).
3. Patients with electrographic evidence of seizures arising from one temporal lobe, with
radiographic evidence of mesial temporal sclerosis in the same temporal lobe will be
included. Patients with normal MRIs, bilateral hippocampal damage, or cortical lesion
will be excluded.
4. Subjects should be on stable doses of antiepileptic medications for at least 3 months
prior to treatment.
5. All female patients of childbearing age will have documented that they are using a
safe and effective means of birth control and will have a negative urine pregnancy
test completed within 1 week prior to their treatment.
6. Patients should be able to understand the potential benefits and risks of this therapy
and be able to understand the protocol and sign their own consent forms. For these
reasons, only patients 18 years and older and with I.Q. greater than or equal to 70
will be included.
7. Patients with any focal neurologic deficit that would make it difficult to detect a
new radiation-associated injury will be excluded. All patients will receive formal
visual field testing (Humphrey) and patients with visual field deficits will be
8. Patients with radiographic evidence of other pathologies such as vascular
malformations or tumors will be excluded.
9. Patients with diabetes mellitus or hypertension will be excluded from this study
because radiation injury to the brain is more common in these patients.
10. Subjects should not have significant psychiatric conditions that would make accurate
assessment of seizure frequency difficult, as judged by the principal investigator.
Such conditions include a history of non-epileptic seizures, psychosis (other than
post-ictal psychosis) and severe mood disorders including suicide attempt within past
12 months or noncompliance with psychotropic medications.
11. Patients with a history of significant past or present medical disorders determined
severe enough to prevent participation in a surgical trial by the principal
investigator are excluded.
12. Patients with any progressive neurological disorder (such as multiple sclerosis or
systemic lupus erythematosis) are excluded.
13. Patients with a history of poor compliance with past antiepileptic drug therapy as
judged by the principal investigator are excluded.
14. Patients with a recent history of abusing drugs or alcohol with significance as judged
by the principal investigator are excluded.
15. Patients who are receiving any investigational drugs at the time of enrollment are
16. Patients with current use of vigabatrin are excluded. Past use does not exclude a
patient pending a normal formal visual field test.
17. Patients with currently functioning vagal nerve stimulators (VNS) are excluded. Past
use does not exclude a patient as long as the device is explanted. Indwelling VNS
electrodes are permitted in agreement with each center’s policies on brain MRI
18. Patients who can not be anticipated to participate for the full 36 months of the trial
will be excluded.
19. Native English speakers from the U.S. or other English speaking countries or patients
who learned English before age 5 and were educated in English. Spanish speaking
patients can be included as long as the study site can provide an officially
translated (IRB approved) consent form in Spanish. Non-Spanish speaking patients with
English as a second language (ESL) and/or non-English and non-Spanish speaking
patients can be included only under the following conditions: 1) the study site must
be able to have the consent form translated into the patient’s native language using
an official translator, and 2) the study site’s neuropsychologist must be willing and
able to assess the patient at baseline and post-treatment at 12, 24, and 36 months in
that patient’s native language to ensure the patient’s safety.
Maternal and Neurodevelopmental Outcomes of in Utero Antiepileptic Drug (AED) Exposure
Epilepsy is one of the most common neurological disorders affecting women of childbearing
age. Poor pregnancy outcomes are increased in these women and their children. The proposed
studies will increase our knowledge on multiple levels to improve care and reduce adverse
outcomes in these mothers and children. An overall goal of this study is to establish the
relationship between antiepileptic drug exposure and outcomes in the mother and child as well
as describe and explain the variability in antiepileptic drug exposure and response.
Inclusion Criteria for All Women
– Pregnant women with epilepsy up to 20 weeks gestation, healthy pregnant women without
epilepsy up to 20 weeks gestation, or non-pregnant women with epilepsy.
– Ability to maintain a daily medical diary.
– Language skills in English or Spanish adequate to perform the cognitive tests and
– Access to a telephone for phone contacts.
– Age 14-45 inclusive.
Inclusion Criteria applicable for pregnant women only. -Ability for follow-up through 6
years after giving birth.
Criteria applicable for non-pregnant women with epilepsy only:
– Minimum of 9 months post live birth, miscarriage, or elective termination.
– Not currently breastfeeding.
Exclusion Criteria for All Women
– Women with an expected IQ<70. - IV drug use in past year or any of the following since the beginning of pregnancy: Alcohol abuse, cocaine, or methamphetamine) or sequelae of drug/alcohol abuse. - History of psychogenic non-epileptic spells. - History of positive Syphilis test. - History of HIV positive test. - Progressive cerebral disease (e.g., multiple sclerosis, progressive brain tumor). - Presence of other major medical illness (e.g., diabetes, cancer). - Any medical, psychiatric, or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs ability to give informed consent. - Concurrent participation in an experimental drug trial. Exclusion criteria applicable for pregnant women only. - Exposure to known teratogens during pregnancy, excluding AEDs. - Detection of fetal major congenital malformation prior to enrollment in current pregnancy. - History of a known genetic disorder in herself or a primary relative (may contact MONEAD team with details for possible exception). - Use of non-licensed midwife as primary source of natal care and/or planning home delivery or delivery at a stand-alone birth center, independent from a hospital. Exclusion criteria applicable for all women with epilepsy. -Planned surgical intervention for epilepsy that would occur during the subject's participation in the project Exclusion criteria applicable for pregnant women with epilepsy only. -History of switching AEDs during pregnancy prior to enrollment. "Switching" AEDs includes changing from no AED therapy to therapy, discontinuing a current AED therapy, or changing to a different AED therapy. Exclusion criteria applicable for non-pregnant women only. - Diagnosed by a health care professional as perimenopausal or postmenopausal. - History of switching AEDs within 90 days of enrollment. "Switching" AEDs includes changing from no AED therapy to therapy, discontinuing a current AED therapy, or changing to a different AED therapy. Inclusion Criteria for Study Family Members - The Father must be the biological father of the child in the study. - The Maternal Relative must be a full biological relative or half-sibling of the mother chosen by the following hierarchy: 1. st choice: Sister of closest age to the mother in the trial 2. nd Sister of next closest age 3. rd Brother of closest age 4. th Brother of next closest age 5. th Mother 6. th Father of pregnant mother in the study 7. th Half-Sibling if NO Primary FULL relatives are available. Exclusion Criteria for Study Family Members - Any medical, psychiatric, or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs ability to give informed consent. [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.
Active, not recruiting