The Promise of Brain-Changing Technology
words by eve jacobs
Giovanni Caracci, MD, and the Neurostar TMS Therapy System at NJMS
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amed Number 5 of CNN’s Top 10 Health Innovations of 2009, a headpiece that focuses MRI-strength magnetic pulses into the brain could potentially revolutionize its behavior. The Neurostar TMS (transcranial magnetic stimulation) Therapy System is a complex name for a noninvasive new technology that was approved in October 2008 by the FDA for treating major depression, and is now being tested as therapy for schizophrenia, brain trauma and other serious and often intractable conditions.
Depression affects 121 million people worldwide, according to the World Health Organization, with 17 to 21 million a year diagnosed in the U.S, accounting for roughly 10 percent of the population. Adults age 40 to 59, African Americans, and economically disadvantaged persons are more prone, and women are twice as likely to be diagnosed as men. Eighty percent of those diagnosed have depression severe enough to impede their home and work lives.
While new and better antidepressant drugs have had an enormous impact for many patients, in 20 percent of cases, medications don’t do enough. “Often, the response to treatment is only partial. TMS is for those individuals who do not get enough benefit from antidepressant drugs,” explains Giovanni Caracci, MD, interim chair of psychiatry at NJMS and head of the new TMS program there. “Now we have another option to offer them.”
A recently published article in the Archives of General Psychiatry, based on more than 800 patients who participated in the multicenter, placebo-controlled clinical trials that launched this device, showed a significant difference in the decrease of depression scores between those treated with TMS and those who were treated with placebo, says the psychiatrist.
“The company producing the device markets it as helpful in moderate as well as major depression. But TMS should only be used after two trials of medications with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Norepinephrine Serotonin Reuptake Inhibitor (NSRI) are unsuccessful,” explains Caracci.
The brain is truly the final frontier, with medical pioneers and their new-age tools finally revealing — and influencing — some of its deepest mysteries; and TMS, a form of brain stimulation, is a technology that is right there at the leading edge. It falls within a broader category of neuromodulation — therapy that alters brain and nervous system activity by targeting electricity to very specific regions. “Psychiatrists concentrate on the brain,” he comments, “while the peripheral nervous system is in the purview of neurologists.”
Neuromodulation can bring about outstanding and life-changing results. Caracci names deep brain stimulation (DBS) for severe Parkinson’s symptoms, other movement disorders like dystonia, and intractable obsessive compulsive disorder (OCD), and spinal cord stimulation for difficult-to-treat pain among its better known uses. But neuromodulation is being used and tested for a wide range of complex health issues, including urinary incontinence, epilepsy, fibromyalgia, drug addiction and obesity.
While most neurostimulators involve the surgical implantation of a pulse generator, power source and leads, with a low-voltage electric current traveling from the generator to the nerve to either block pain signals or stimulate nerve impulses, TMS therapy is far simpler. At the UMDNJ center, the patient reclines on a comfortable chair in a quiet room with windows, can nap, read, listen to music, watch TV, or do nothing, and walks out 45 minutes later, never having seen a hospital. There is no anesthesia or surgical cut.
“This is unlike ECT— electro-convulsive shock therapy,” says Caracci. “The ECT patient needs anesthesia, and side effects often include loss of memory around the event. And the relapse rate is high within three to six months.”
“However, ECT remains the treatment of choice in major depression with psychotic features and it is a life-saver in extremely severe conditions such as neuroleptic malignant syndrome and catatonia,” he explains.
For TMS, a headpiece attached to a machine that emits strong, targeted electromagnetic pulses is precisely positioned over the patient’s head. According to Caracci, the “mapping” of the targeted area — which is about as big as a golf ball — is extremely precise and important, and involves computerized mathematical positioning. The therapy is based on the premise that depressed patients have an underactive prefrontal cortex, he explains, and the stimulation must hit that precise area of the brain. This is what happens:
- The patient comes to the therapy room every weekday for four weeks (some may come for a fifth or sixth week).
- For the first session, the patient spends approximately two hours, which includes initial mapping of the head to find the area of the brain to be stimulated.
- Thereafter, patients will spend about 37 minutes in the chair for each treatment.
- At every session, a headpiece is fitted around the scalp area. This headpiece has a treatment coil, which is applied to the head above the left prefrontal cortex. As they move into the brain, the magnetic fields produce small electric currents that activate cells in the brain, which then release neurotransmitters.
- A series of pulses — about 3,000 over the 37 minutes — are directed to the specified area. There are 24 seconds between pulses.
- At the end of each session, the patient can leave the therapy room immediately — there is no recovery period.
Caracci says this approach feels much kinder and gentler than ECT: “The only complaints are from those who don’t like the sound of the pulses, which are a bit like gunfire, but we can give them earplugs. Some may have a small amount of discomfort in the scalp. And rarely, there’s some twitching.” He also says no one should expect a miracle the first week — the effect is cumulative; and that patients remain on their medications during the TMS therapy, although doses may be lowered if the patient is doing well after two to three weeks.
“Individuals who are depressed often have co-existing mental health disorders, and other conditions, such as migraines, fibromyalgia, and neuropathic pain. We are trying TMS for all of these,” the psychiatrist explains.
The industry of neuromodulation is still in its infancy, but its promise is huge. For many brain and nervous system diseases, there are no drugs that work well. In other cases, the drugs work well for some people and not at all for others, or their effectiveness wears off. In the cases of brain injury and stroke, science has hit a lot of walls so far, leaving tens of thousands of patients with little or no help.
“Better options for depression treatment are certainly needed,” says Caracci. “But this technology holds promise for many other conditions — such as autism, Tourette’s syndrome, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and depression in mild to moderate brain trauma — where there is currently so little to offer.” He hopes to partner with scientists at rehabilitation centers to study this technology for those who have traumatic brain injury and do not respond, or can’t tolerate, medications.
He is even hoping that TMS may have a positive effect for patients with amyotrophic lateral sclerosis (ALS) — for which there is currently no good drug therapy. “It’s not a cure but there is some evidence that TMS could slow down the disease,” he says.
“This is all experimental,” Caracci concludes, “but I’m enthusiastic. I want to try. Whatever we can do for patients who have no good medical options is better than what they have now.” .
For more information on TMS therapy, call: 973-972-0829.