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Research:
Investigational Treatments and Drug Trials for Epilepsy

Seizures can usually be brought under control with antiepileptic medication. However in one third of patients, seizures persist despite trials of numerous drugs. For those individuals, we consider alternative approaches, including neurosurgical removal of the seizure source from the brain, the ketogenic diet, and hormone therapy.

For some patients, surgical removal of the source of their seizures is not possible, because this area might be in a critically important part of the brain and the risks of surgery would be too great; or there might be multiple seizures sources. For these people, experimental implanted electrical brain simulators may prove helpful. At the Comprehensive Epilepsy Center, we are conducting investigational trials of two methods of brain stimulation for epilepsy: stimulation of the anterior nucleus of the thalamus, and the responsive brain stimulator.


Investigational Treatments

Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
The thalamus makes electrical connections with many parts of the brain, and stimulation there may oppose a patient's epilepsy and reduce seizures. Thalamic stimulation is already in use to treat tremor and stimulation of a nearby brain region, the subthalamic nucleus, is now being used to treat Parkinson's disease.

For stimulation of the anterior nucleus of the thalamus, the stimulating electrodes are surgically placed through dime-sized holes in the top of the skull, and are connected to a battery pack in the chest by thin wires that run under the skin. Patients with brain stimulators still take antiepileptic medications. However, rather than coming to their doctor for medication prescription changes, patients in the stimulation of the anterior nucleus of the thalamus study come to get their stimulator settings reprogrammed with a magnetic device that the treating doctor uses to send information through the skin.

Contact: Dr. Douglas R. Labar
Phone: (212) 746-2359
Fax: (212) 746-8845


Responsive Brain Stimulation for Epilepsy
Responsive brain stimulation functions by delivering a counter-shock to the seizure source in the brain at the moment a seizure starts. This is thought to interrupt the seizure and stop it before it spreads and becomes severe.

The responsive brain stimulator employs a small battery-operated computer that is surgically implanted in the skull to detect the abnormal brain electrical activity that represents a seizure. This tiny computer is connected with thin wires to an electrode implanted in the brain at the seizure source. When the device detects a seizure, it immediately sends a counter-shock to block it.

Patients with brain stimulators still take antiepileptic medications. However, rather than coming to their doctor for medication prescription changes, patients in the responsive brain stimulator study come to get their stimulator settings reprogrammed with a magnetic device that the treating doctor uses to send information through the skin.

For more information on stimulation of the anterior nucleus of the thalamus, the responsive brain stimulator study, or other new epilepsy treatments available at New-York Presbyterian Hospital/Weill Cornell Medical Center, please contact the Comprehensive Epilepsy Center:

Contact: Dr. Douglas R. Labar
Phone: (212) 746-2359
Fax: (212) 746-8845


Investigational Drug Trials

Before a medication is available by prescription, it is extensively tested in the laboratory for safety, effectiveness, and effects on reproduction. Later, when the medication is shown to be safe, it is tested for long-term safety and effectiveness on patients. These tests are called investigational drug trials.

At NewYork-Presbyterian/Weill Cornell's Comprehensive Epilepsy Center, FDA-approved investigational drug trials have made new, investigational antiepileptic medications available to our patients. Through clinical trials, we have had extensive experience with newer agents such as gabapentin, topiramate, tiagabine, lamotrigine, zonisamide and levetiracetam.

All investigational trials are approved by the FDA, which closely supervises the study along with the epilepsy center staff and the company providing the medication. Patients enrolled in an investigational study receive very close follow-up care and careful medical supervision to assure that no problems arise during the trial. Most investigational drug trials provide the medication under study at no cost, as well as free comprehensive care (laboratory tests and studies — EEG and MRI in some cases — and doctors' visits) and travel compensation for patients.

The Comprehensive Epilepsy Center is currently investigating several drugs. These drugs are listed below along with a brief description of the study and contact information.

Natural Progesterone Study (AED)
We are conducting a National Institute of Health-sponsored study to evaluate the effect of progesterone on seizures that are related to menstruation. The worsening (exacerbation) of seizures in relation to the menstrual cycle is called catamenial epilepsy. The frequency and severity of seizures correlates with the level of certain hormones in the blood. For example, women with temporal lobe epilepsy may experience mood disturbance with exacerbation (worsening) related to the menstrual cycle.

Progesterone has been shown have an antiseizure effect that may be helpful to some women with epilepsy. Natural progesterone and other hormonal therapies can also be used to effectively treat severe pre-menstrual syndrome and cycle-related disorders of mood and thought. Women with epilepsy who suffer from catamenially-related anxiety, panic attacks and agitated depression often show a favorable response to treatment with progesterone or other agents.

At the Comprehensive Epilepsy Center, a neuroendocrinologist guides the treatment of women with catamenial epilepsy. To qualify for this study, you must have seizures and be a female between the ages of 18 and 45 with regular menstruation.

Contact: Dr. Cynthia L. Harden
Phone: 212-746-2346
Fax: 212-746-8845

Talampanel Study (AED)
A research study to determine the effects of Talampanel, an investigational drug, in the treatment of epilepsy. To qualify for this study, you must have seizures. This is a study for both males and females.

Contact: Dr. Cynthia L. Harden
Phone: 212-746-2346
Fax: 212-746-8845

Additional Information
Epilepsy Clinical Trial
SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
NeuroPace:Clinical Trials
 
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