Trial Information

Summary: Trigeminal Nerve Stimulation for Epilepsy

We are actively recruiting subjects for a research trial investigating a new treatment for poorly controlled epilepsy.

The purpose of this study is to determine if electrical stimulation of the trigeminal nerve, a small nerve located under the eyebrows, reduces seizures in people with epilepsy. Information from animal studies, and from a small human study, indicates that stimulation of this nerve may improve seizure control.

Trigeminal Nerve Stimulation involves the use of patch electrodes placed over the forehead connected to a battery- powered neurostimulator.

Side effects are generally mild, and may include, skin irritation, headache, and waking up at night.

Patient Inclusion Criteria:

• Ages 18 - 70
• No serious or progressive neurological, psychiatric or medical illness
• A history of intractable partial seizures
• At least two complex partial or secondary generalized seizures per month in the last two consecutive months
• MRI or EEG consistent with localization-related or partial epilepsy
• Exposure to at least two antiepileptic drugs at adequate doses
• Concurrent use of at least one antiepileptic drug at adequate doses
• No change in antiepileptic dose for at least 30 days before study enrollment

Patient Exclusion Criteria:

• History of non-epileptic seizures
• Inability to maintain accurate seizure calendars (self or caregiver)
• Clusters of seizures during which the exact number of seizures cannot be enumerated
• Frequent use of benzodiazepines for clusters defined as greater than four times a month
• History of facial pain or trigeminal neuralgia
• Concurrent vagus nerve stimulation
• IQ less than 70, or inability to understand the informed consent
• Pregnancy

If you would like to learn more about participating in this study, please send an e-mail message using the form below.