Thursday, July 27, 2006

Trigeminal Stimulation as an Epilepsy Treatment

Filed under: Neurology

UCLA is reporting about early efforts to control epilepsy via trigeminal nerve stimulation. In the study of seven patients at the David Geffen School of Medicine, trigeminal stimulation using electrodes from Valencia, Calif.-based Advanced Bionics Corp., has resulted in four subjects reporting "50 percent or better reduction in seizure frequency."

"Most people with chronic epilepsy who have continuing seizures are drug-resistant," said Dr. Christopher DeGiorgio, vice chair and professor in residence of neurology at UCLA, and co-developer of TNS and lead author of the study. "In addition, anti-seizure drugs can have significant side effects on behavior, thinking and alertness. Women taking anti-seizure drugs and their unborn children are at special risk because of the effect of these drugs on fetal growth and development.

Unlike VNS [vagus nerve stimulation -ed.] , the TNS stimulator can be tested externally to gauge results before implanting the device. Patients treated in the clinical trial wore the stimulator on their belt. Wires from the stimulator were passed under clothing and connected to electrodes attached to the face by adhesive. The electrodes could be covered by a cap or hat.

In addition, while VNS stimulates only one side of the brain, TNS stimulates both sides, a theoretical advantage that will require more testing to validate and quantify.

The cost of an external TNS stimulator is about $180. The monthly retail cost of batteries and electrodes is $150 to $170.

Originally tested in animal studies by researchers at Duke University, TNS was developed and used for the first time in humans at UCLA in the recently completed pilot study outlined in Epilepsia. The research is being conducted using a grant from Advanced Bionics.

DeGiorgio is currently enrolling patients in a follow-up study that will seek to extend the findings to 25 patients. A third study will examine the impact of implanting TNS with an electrode under the skin (just beneath the eyebrow) of patients who respond to the external stimulator.

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replies: 3 comments
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Vagus nerve stimulation (VNS) is a mildly invasive procedure that is also FDA approved for chronic or recurrent treatment-resistant depression.

I was implanted with the device in the investigational trial of vagus nerve stimulation for the treatment of depression. VNS completely changed my life after over 20 years of countless antidepressants/antidepressant combinations.

Epilepsy and depression are co-morbid diseases. VNS has the potential to treat patients with epilepsy and who suffer from depression

Charles E. Donovan
Author
Out of the Black Hole: The Patient's Guide to Vagus Nerve Stimulation and Depression
VagusNerveStimulation.com


Posted by: Charles Donovan
on July 30, 2006 06:41 PM GMT

The VNS and TNS use the same nerural ways(from Brainstem: Nucleus Solitary Tractus, etc) to carry their info toward upper brain structures. With these in mind, it is reasonable the TNS features.
Very fascinating research.!!


Posted by: Jose Maglione
on August 1, 2006 10:56 AM GMT

With all due respect to Mr. Donovan and his comments, VNS is not the be-all and end-all of seizure control.
I also have had a VNS implanted for almost two years and although it indeed has controlled my seizures better than must medications, it has actually made my quality of life worse by far.

The reason is a side effect of using the VNS that happens to probably 10% or more of its users and potential implant candidates are NOT advised of this potential side effect. I only found out by going into the physician portion of Cyberonics' web site.

There are actually two side effects, one of which they do advise candidates about. That is atrial fibulation. That is erratic heartbeat. Because I already suffered from this problem, before implanting the VNS I had this heart condition corrected by having an ablation. This is where they electrically burn the heart tissue that is generating the extra electrical signals that cause afib. This corrected the problem just fine.

The second, and in my view far worse side effect, is that the VNS can either cause or worsen sleep apnea. Sleep apnea is a condition where you may be sleeping consciously, but your brain is not at rest and one of the activities it is doing is causing you to stop breathing. After your blood is depleted of oxygen, your brain tells your lungs to breath again. This is extremely exhausting and even though you may find yourself sleeping 10-12-14 hours a day, the moment you wake up you feel as though you haven't slept for several days. You are not refreshed and you become more and more inactive, more depressed at your inability to perform the simplest activities without becoming so exhausted that it begins to become painful and with this lack of rest you find yourself actually having more seizures than before the VNS was installed.

The major question I have about the TNS is has anyone studied its effects in this area since Mr. Donovan says they both use the same pathway to the brain and there is some suspicion that brain stimulation while asleep may be the reason for the sleep apnea side effect?

I personally don't agree with this theory and there has been no reliable studies done by Cyberonics or anyone else to pinpoint just why the VNS is causing sleep apnea to develop in people who have never had sleep apnea before installing this device.

My own opinion is that since the diagnosis of sleep apnea in my case, is obstructive sleep apnea and two different Ear, Nose and Throat specialists have determined that there is no obstruction in my throat or windpipe, that the sleep apnea is possibly caused by the constant irritation of the throat area from the electrical discharges. This causes thick mucous to form in the windpipe and restricts the flow of air through the windpipe.

If I am right and this turns out to be true, then the TNS will be a much better solution than the VNS for seizure control. This would be because the electrical discharges would be in the forehead and not the throat, so the problem of mucous buildup would not be present.

Aside from this, removing the electrical discharges from the throat area will solve another problem that the VNS presents, hoarseness of speech and paralysis of the left vocal chord. These are additiononal side effects that are, at least fir the hoarseness, universal in all VNS users.
The paralysis of the vocal chord is not universal but is very frequent because of the constant electrical discharges in the area of the vocal chord and the intensity of those discharges. When first using the VNS they are so intense that you cough and actually have to stop speaking.

So for all of these reasons, even if the sleep apnea is caused by brain stimulation and not windpipe blockage, the TNS should be far superior to the VNS unless the people from Cyberonics develop an alternative site for the attachment of the lead to the Vagus Nerve. Two doctors have developed an alternate method of installation that appears promising. They install the lead from the rear of the neck instead of the front, next to the Adam's Apple as Cyberonics instructs the installation to be. This causes the lead to be attached further from the windpipe and the left vocal chord. I have written to one of the two Doctors who developed this alternate installation method in order to get more data on the actual attachment point but have not received a reply from him yet.

So the bottom line is that unless Cyberonics changes the installation method for the VNS, the TNS is looking to be a better solution for some people with intractable seizures.


Posted by: Dale Johnson
on August 17, 2006 01:33 PM GMT