Clinical Trial Details
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NCT02383407 : Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)
AgesMin: 18 Years Max: 65 Years
Inclusion Criteria:

- Participants are between the ages of 18 -65 years of age

- Participants must have had a non-invasive video-EEG monitoring revealing seizure
semiology and ictal EEG consistent with unilateral or bilateral MTLE

- Participants must have tried and failed two trials of antiepileptic drugs (AEDs)

- Participants with lesional or non lesional hippocampus

- Participants are prescribed and taking 1-4 AEDs at the time of study entry

- Brain MRI acquired within the previous two years is with evidence of abnormalities
of the hippocampi

- Demonstration that the hippocampus ipsilateral to seizure onset is contributing to
memory function. For example, this evidence may be inferred from seizure semiology,
neuropsychological testing, positron emission tomography, intracarotid amobarbital
test, functional magnetic resonance imaging, or any other assessment that should
light on lateralization of memory processing.

- Study participants will have intractable (MTLE) with a seizure frequency of at least
1/month averaged over the preceding 6 months prior to enrollment, including maximum
seizure-freedom periods of no more than 60 days.

- Participants must have a platelet count greater than 125,000 per cubic millimeter and
prothrombin time (PT) and activated partial thromboplastin time (aPTT) within normal
limits at the visit prior to surgery

- Not candidates for resective surgery for reasons that include an increased risk of
memory decline

Exclusion Criteria:

- Progressive neurological or medical diseases, such as brain tumors or
neurodegenerative disease or cancer

- Non-compliance with antiepileptic medications as demonstrated by the medical record

- Any conditions interfering with electrode implantation

- Any non-epileptic seizures

- Any participant who may be a surgical candidate for resective surgery

- Inability or unwillingness to complete neuropsychological tests or complete seizure

- Current drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study requirements

- Pregnant, or planning to become pregnant*

- Participation in another research trial where the participant was treated with
another investigational drug or device within 30 days prior to enrollment of study

- IQ less than 70 or inability to understand study procedures and to comply with them
for the entire length of the study

- Inability or unwillingness of individual to give written informed consent

- Participants who have changes to their antiepileptic medications during the baseline
phase (as they will need to repeat the baseline phase)

- Subjects with history of status epilepticus within the preceding year

- History of psychiatric illness necessitating hospitalizations

- Subjects who have any of the following implanted devices: aneurysm clips, cardiac
pacemaker or defibrillator, cochlear implant, spinal cord, DBS, or vagal nerve

- Co-morbid conditions that would interfere with study stimulation activities or
response to treatment, which may include:

- Neoplasm with life expectancy < 5 years

- Severe chronic pulmonary disease

- Local, systemic acute or chronic infectious illness

- Life threatening cardiac arrhythmias

- Severe collagen vascular disorder

- Kidney failure or other major organ system failures
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