Surgery ended seizures and changed his life

Brain pace maker: Implanted device can help control seizures, mood

Now that he is seizure-free, Ian Sinclair of Quincy can play with with his nieces and nephew without risk.

When his nephews were babies, Ian Sinclair, 30, couldn’t hold them because they’d fall if he had one of his frequent, sudden seizures. So he was delighted to cradle his infant niece recently, nearly two years since a surgical implant ended the seizures that began when he himself was a baby.
‘‘I was not expecting complete relief,’’ said Sinclair of Quincy. ‘‘Even to this day I and members of my family can’t believe it. I have the option now to get my life back on track. It’s a blessing where I can take a few steps toward my goal of independence.’’

The breakthrough epilepsy treatment is called Vagus Nerve Stimulation (VNS) therapy. But it’s popularly called ‘‘a pacemaker for the brain,’’ since a pacemaker-like device is implanted in the patient’s left chest. From there, it sends mild, intermittent doses of electrical stimulation through thread-thin wires to the left vagus nerve in the neck, which connects to the brain. In ways not totally understood by researchers, the electrical discharge effects parts of the brain involved in seizures and mood disorders.

In Ian’s case, the result has been a complete cessation of seizures since December, 2003. More typically, patients still have seizures, only less frequently and less severely, said Sinclair’s neurologist Dr. Georgia Montouris, co-director of Epilepsy Services at Boston Medical Center and assistant professor of neurology at Boston University School of Medicine.

What’s more, they recover from those seizures more quickly, and they need less medication, which reduces the side effects of osteoporosis, lethargy, weight gain and confusion.

‘‘I’m not trying to say that this is the best thing since sliced bread, but for a lot of people, it has made a major difference,’’ Montouris said.

Montouris has had about 130 patients receive the device, which weighs about an ounce and is the size of a pocket watch. More than 75 percent improved significantly, she said.

Since the Federal Drug Administration approved VNS for epilepsy in 1997, 30,000 patients worldwide have received it, according to the manufacturer, Cypertonics. And it’s application is growing, since the FDA just approved it in July for treatment of depression, which affects about 40 percent of patients with epilepsy. VNS clinical trials now are under way to study its usefulness in treating anxiety disorders, Alzheimer’s disease, bulimia and chronic headache/migraine.

In contrast to VNS’s impact on seizures, it appears to be less effective for severe depression, but nonetheless offers possibilities when other treatments have failed.

‘‘I see many (depressed) patients for whom nothing works,’’ said psychiatrist Linda Carpenter, who conducted the clinical trial at Butler Hospital, affiliated with Brown University Medical School in Providence. ‘‘I feel for many patients it offers hope. There’s a good chance they will feel a little better and a smaller chance they’ll feel somewhat better.’’

A year after implant, 30 percent of patients had a 50 percent reduction in symptoms based on the Hamilton Depression Rating Score, compared to 13 percent on medication only, according to Cypertonics.

‘‘Some patients will say, ‘It’s not for me,’’’ Carpenter said. ‘‘Others will say ‘those are sort of low numbers, but I’ll take any alternative.’’’

That was Sinclair’s viewpoint when he decided on VNS.

‘‘I was biting my tongue and my body would contort and several times I cracked my skull when I fell,’’ he said. ‘‘Afterwards, I wouldn’t be able to move for 24 hours. I was having seizures sometime five times a week, and I was willing to try anything.’’

Sinclair still faces challenges, coping with the memory and learning deficits caused by so many seizures that began when he was 18 months old and worsened following a head injury during an attempted robbery outside a Burger King he managed. But he doesn’t expect these to stop him from getting his driver’s license and returning to work.

Head trauma, in fact, is one of the major causes of epilepsy, along with congenital defects and compromised blood flow in the brain. The two peak times for onset are in children under age 10 and adults over age 60.

As common as diabetes, epilepsy is the second leading neurological disorder. About one percent of the population, or 2.4 million Americans, has epilepsy and about 181,000 new cases are diagnosed each year, according to the Epilepsy Foundation of America. Of these, about 30 percent are not helped by anti-epileptic drug therapy and become candidates for VNS.

VNS, though, is not without risks, since it is a surgical procedure, Montouris said. Although it is performed outpatient and takes 45-60 minutes, risks include infection, blood clot and vocal chord damage. The most common side effects are a wispy voice, which Sinclair experiences, as well as tickling in the throat and shortness of breath occurring during the electrical charge. These typically diminish over time.

Once the implant is complete, the doctor programs the timing and duration of the electrical charge, simply by waving over the device a wand that is connected to a palm pilot size computer. Sinclair, for example, receives 30 seconds of stimulation every five minutes, though the dose is different for every patient. It also can easily be adjusted by the physician during a patient’s follow-up visits.

VNS therapy costs about $20,000 to $25,000, reimbursed by most third party payors as well as Medicare and Medicaid in most states. So far, it is more difficult to get insurance coverage for VNS therapy in the treatment of depression, although that could change as more studies are conducted, Carpenter said.

Currently, psychiatrists haven’t widely endorsed VNS therapy because its has not undergone the same type of clinical trials the FDA requires before approving medications, Carpenter said.
‘‘The FDA has a different standard of approval for devices and there is a huge number of psychiatrists who ask whether the level of proof is good enough,’’ she said. ‘‘Some doctors want to wait until there is more data.’’

In the meantime, Sinclair has a new sense of security. Clipped to his belt is a small magnet that he can pass over the implant to produce extra stimulation if he feels a seizure developing. His relatives also have magnets.

‘‘If they feel it coming on, they can abort or shorten the seizure,’’ Montouris. ‘‘It’s very empowering for patients.’’

DEFINITIONS

—EPILEPSY: an illness characterized by recurrent seizures.

—SEIZURE: a disturbance in the electrical activity of the brain. It can symptoms ranging from twitching fingers, unrecognizable speech, convulsions and even unconsciousness.

—VAGUS NERVE: the body's ‘‘information super highway,’’ connecting the brain and many major organs.