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New Hope For Epilepsy Patients: Experimental Regenerative Brain Cell Therapy
Doctors at UC San Diego Health recently performed a clinical trial surgery involving the injection of regenerative cells into a patient's brain that could be used to treat epileptic seizures. This surgery marks just the third time such a procedure was performed and is a part of a national clinical trial designed to use human stem cells to provide epilepsy patients with a non-destructive option for those whose temporal lobes exhibit drug-resistant characteristics.
Dr. Sharona Ben-Haim, MD, seen performing only the third ever experimental regenerative brain cell therapy for epilepsy in July 2023, which is part of a national clinical trial designed to eliminate seizures, thus revolutionizing the treatment of temporal lobe epilepsy. (Credit: UC San Diego Health)
"This experimental therapy offers us the potential to essentially restore the balance in the brain to be able to calm and ideally stop the seizures, while retaining the normal function of that part of the brain," said Dr. Sharona Ben-Haim, MD, who is an associate professor of neurological surgery at UC San Diego School of Medicine, and who performed the experimental procedure. "Currently, we do not have a therapy that allows us to do that, so this is really exciting."
During the procedure, Dr. Ben-Haim carefully examined the magnetic resonance imaging (MRI) scans of the patient's brain to navigate where to inject the human stem cell-derived inhibitory brain cells, also called interneurons. The stem cells are designed to create what's known as gamma-aminobutyric acid (GABA) which is a commonly known neurotransmitter that inhibits hyperactive impulses that might occur between brain cell nerves and is known for reducing both stress and anxiety while improving sleep. Sponsored by Neurona Therapeutics, the goal of the clinical trial to sign up 40 volunteers across the United States to take part in the study. After the procedure, Dr. Ben-Haim examined her work with the aid of a 3D digital image.
Dr. Sharona Ben-Haim, MD, with a 3D digital image of the procedure. (Credit: UC San Diego Health)
The Centers for Disease Control and Prevention (CDC) reports that approximately 3.4 million Americans—3 million adults and 470,000 children—suffer from epilepsy with about one-third being resistant to anti-seizure medications. Additionally, adults suffering from the disorder describe worse physical and mental health, along with financial difficulties from being unable to afford various forms of health care in contrast to adults without the disorder.
The World Health Organization reports that approximately 50 million people suffer from epilepsy around the world, with an estimated 75 percent of those individuals in low-income countries not receiving proper treatment. What makes this new procedure groundbreaking is its non-invasive method to treat epileptic seizures, since conventional surgical therapies involve laser-burning or removing the epileptic parts of the brain.
"This first-in-human clinical trial represents a paradigm shift in the way we treat this disease process, shifting from procedures that destroy bad tissue to procedures that repair the bad tissue," said Dr. Jerry Shih, MD, who is a professor of neurosciences at UC San Diego School of Medicine, along with being a neurologist and director of the Epilepsy Center at UC San Diego Health. "Our hope is that this procedure has such a high success rate and good tolerability that it becomes the standard of care for all drug-resistant focal epilepsies."
While this was only the third ever procedure of this type, initial results released in June 2023 indicate a 90 percent drop in seizure frequency for the first patient one year after surgery and seven months after surgery for the second patient. The goal is to monitor each patient for up to two years after the procedure.
What new discoveries will surgeons make about controlling epileptic seizures with this new procedure in the coming years and decades? Only time will tell, and this is why we science!
As always, keep doing science & keep looking up!
Sources: EurekAlert!, U.S. National Library of Medicine, UC San Diego Health, Cleveland Clinic, Neurona Therapeutics, Centers for Disease Control and Prevention, World Health Organization
Women, Epilepsy, And Sexuality
Epilepsy and the medications used to control seizures can affect a woman's sexual health. Infertility, sexual dysfunction, higher rates of birth defects, and even osteoporosis are real issues for women with seizures.
While we may know more now than in the past about women with epilepsy, many misconceptions still persist.
"Informal surveys at both the local and national levels show that women with epilepsy consistently report a lack of knowledge about the difficulties they face," says Patricia Shafer, RN, MN, past chairman of the professional advisory board of the Epilepsy Foundation, who herself suffers from the disorder. "And a survey of health-care professionals, conducted a few years ago, revealed a lack of knowledge or uncertainty about what to do in terms of pregnancy management or problems of sexuality in such cases."
Though Shafer and other experts who spoke with WebMD agree that strides have been made in understanding the unique problems facing women with epilepsy in the past few years, they point to a new dilemma: Getting the message out to general care practitioners and their patients.
"Many women tell me they're aware of [some of the new findings]," says Shafer, who is also an epilepsy nurse specialist in the Comprehensive Epilepsy Center at Beth Israel Deaconess Medical Center in Boston. "But they don't follow through."
Alison Pack, MD, assistant professor of clinical neurology at Columbia University in New York, agrees. She and others are channeling their efforts at spreading the word on three of the main problems women with epilepsy face: reproductive health; bone health, particularly as a woman approaches menopause; and pregnancy.
No one really knows exactly how seizures affect reproductive health, but there seems to a hormonal connection, experts say. According to Pack, the female hormones estrogen and progesterone act on certain parts of the brain where partial seizures often begin. Estrogen excites these brain cells and can increase the risk of seizures, while progesterone can inhibit or prevent seizures. Not all women with epilepsy develop seizures during their periods, and it is not clear why some women are more at risk.
"Since progesterone levels drop during menses, that may render a woman more susceptible to a seizure during that time period," she explains.
In Boston, Andrew Herzog, MD, director of the Neuroendocrine Unit at Beth Israel Deaconess Medical Center, is working on a large National Institutes of Health-sponsored study designed to provide new answers. While final answers are still years away, preliminary evidence suggests that giving progesterone during menstruation may help to assuage hormone-related seizures.
But not all the news is good: Other studies have shown that some older epilepsy drugs, particularly valproate (sold under the brand names Depakote, Depakene, and Epivil), can interfere with ovulation, Pack tells WebMD. And that, in turn, can lead to infertility and long-term health problems, including high cholesterol levels, certain female-specific cancers, and diabetes, she says.
And the list doesn't end there: "Women taking valproate also report excess weight gain and hair growth," Pack says. Also, a recent study at Columbia University showed that women who took valproate at any time during the past three months were at increased risk of developing cysts in their ovaries.
"The bottom line," Pack says, "is that I tend not to prescribe valproate as a first-line drug for most women with epilepsy who are in their reproductive years. That's not to say that valproate is not a good drug, but with so many other choices available, [for these women] I tend to pick something that won't have these side effects."
While a variety of factors need to be considered when choosing a medication to control seizures in women with epilepsy, Pack says many neurologists have indicated a preference for Lamictal due to its relatively safe side-effect profile.
According to the Epilepsy Foundation, Lamictal neither increases the breakdown of female hormones nor interferes with the effectiveness of hormonal birth control, unlike other seizure medications.
But for women with epilepsy who also suffer from migraine headaches, Topamax is usually considered the drug of choice because of its headache-relieving properties, Pack says.
Given the complex interactions between hormones and seizures, it's not surprising that certain seizure medications can prevent birth control pills from working effectively, experts note. These medications can affect a system in the liver that breaks down medications. According to the Epilepsy Foundation, the so-called "liver enzyme-inducing" drugs -- Tegretol, Dilantin, phenobarbital (Luminal), Mysoline, and Topamax -- increase the breakdown of contraceptive hormones in the body, making them less effective in preventing pregnancy. Valproate and Felbatol, on the other hand, can actually raise hormonal levels, which may require an adjustment in dose.
Like Lamictal, Neurontin has no effect on hormonal balance and thus does not interfere with the effectiveness of birth control pills.
No matter what seizure medication you are on, it's important to realize that the popular "mini-pill" has too little estrogen -- less than 35 micrograms -- to protect women with epilepsy from becoming pregnant. The reason: Many of the commonly prescribed seizure medications reduce the amount of time that hormones are in your bloodstream, Shafer says.
Her advice: "Talk to your doctor about what type of contraception is best for you." In many cases, a combination of a pill and a barrier method may be the best option.
Problems with low sexual desire, difficulty with arousal, and painful intercourse are not uncommon among women with epilepsy. According to Pack, there are a variety of reasons for such problems, many of which can be helped by a doctor or therapist. Some women may experience feelings of low self-esteem, for example, while others may have vaginal dryness caused by the disease itself.
"As embarrassing as it may be, it is important to speak openly with a health-care professional you trust as many of these problems can be solved," Pack says.
Though bone health is of concern to all women as they age, women with epilepsy face unique challenges, Pack says.
"Some of the older medications such as phenytoin (Dilantin) and phenobarbital have been shown in studies to raise the risk of osteoporosis, which in turn can raise the risk of bone fractures," she tells WebMD. And in Pack's own trial of 70 women, those taking Dilantin had decreased bone density at the hip at one year compared with those on other drugs.
Pack notes that "we really don't have good data yet on some of the newer agents, [but] preliminary data suggests that valproate may also have a negative effect, increasing the risk of bone turnover, a precursor of osteoporosis."
Since many of the anti-epilepsy drugs increase the risk of developing the bone-thinning disease osteoporosis, women with epilepsy should ask their doctors about bone-boosting supplements and annual bone density scans, experts tells WebMD. Some seizure medications interfere with the absorption of vitamin D, the vitamin that is necessary to help build strong bones.
Be sure to get the recommended dietary allowance of both calcium and vitamin D in the diet, Pack says. The typical recommended intake of vitamin D in women of childbearing age is 200-400 IU. For calcium, the recommended intake is 1,000-1,400 mg per day.
Though women with epilepsy were once discouraged from having babies due to the health risks of mother and fetus alike, more than nine in 10 of such women now have healthy babies. Nevertheless, there are special concerns to be faced.
Though some women say they would rather go off their medication during pregnancy than risk hurting their fetus, doctors generally advise against this.
"It really depends on the individual," Pack says. "Some women must continue to take their drugs or they will have a seizure, and that could be worse to both the mother and the fetus than not taking the drug. There's a risk of preterm delivery, miscarriage, and decreased oxygen to the brain that can result in permanent brain damage, even death."
On the flip side, there is a chance that some anti-seizure drugs can cause birth defects in the newborn. And it's not a concern to be taken lightly: The anti-epileptic drug phenobarbital went on the market in 1912, but it was not until the 1990s that articles about its harmful effects on the fetus began to appear, says Lewis Holmes, MD, professor of pediatrics at Harvard Medical School and chief of the pediatric and teratology unit at Massachusetts General Hospital in Boston.
Because some seizure medications are known to lower levels of folate, which is associated with birth defects, women of childbearing age should take folate supplements (400 mg per day) as part of a healthy diet.
Holmes, director of the Harvard-based Antiepileptic Drug (AED) Pregnancy Registry, says his group's goal is to detail the risk of birth defects in women taking widely used anticonvulsant drugs. So far, his team has released two reports, the most recent on babies born to 149 women who took the anticonvulsant drug valproate during pregnancy.
About 11% of the newborns developed major birth defects, including heart abnormalities, extra fingers, kidney problems, spina bifida, and clubfoot. In comparison, only 1.6% of babies born to women not exposed to any antiepileptic drug had a defect, according to the study, presented in 2003 the 23rd Annual Meeting of the Society for Maternal-Fetal Medicine.
An earlier report by Holmes, published in the journal Teratology in 2001, revealed an elevated rate of fetal malformations, particularly cleft lip and palate and heart defects, in babies of women being treated with phenobarbital.
And in October, researchers from the U.K. Reported significant reductions in IQ scores among children whose mothers took the epilepsy drug valproate during pregnancy. These children's IQs were found to be "in the low average" range.
Holmes urges any woman with epilepsy who is thinking about getting pregnant or who is pregnant to call the AED Pregnancy Registry at (888) 233-2334. "It's important to enroll early -- before you know the outcome of the pregnancy," he says. "And be reassured that your name will not be given to your insurance company or anyone else."
If you have epilepsy and are thinking about getting pregnant, here is the experts' advice:
As for folic acid, "most of us recommend at least 1 mg, and if you're actively trying to get pregnant, up to 4 mg a day," she says. But Holmes is a little less enthusiastic. "Everyone has hoped that 'if you take folic acid, you will avoid babies with birth defects," he says. "That may be true in the case of spina bifida. But the mothers of all of the babies in our study who developed birth defects were taking folic acid. We're hoping higher doses will help, but that is just a hypothesis."
As for epilepsy nurse Shafer, she says she gave birth to a healthy boy 12 years ago. "He was the perfect baby," she says. "He did have an occasional seizure, but they waned this summer. With the proper care, hopefully any couple with epilepsy can have the same fulfilling experience as me."
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