Implanting some hope
It's not a cure, but electrodes placed in diaphragm of patients with ALS may buy ease of breathing, and time
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BY JAMIE TALAN
jamie.talan@newsday.com


March 22, 2007

It's been almost two years since Philip Carlo was diagnosed with amyotrophic lateral sclerosis, leaving him little hope that his daily five-mile biking would continue untested by the debilitating motor neuron disease.

ALS weakens muscles and leads to eventual paralysis and death. Yesterday, the New York author became the first patient in a new trial of a surgical procedure that does not promise a cure but may lengthen his life.




In the surgery, previously used on Christopher Reeve and other ventilator patients with spinal cord injuries, electrodes were implanted in Carlo's diaphragm to stimulate and strengthen muscles that will help him breathe on his own. ALS patients live an average of five years after diagnosis. With progressive damage to motor neurons, they become unable to breathe without a ventilator.

A pilot study of 16 ALS patients conducted by Carlo's surgeon, Dr. Ray Onders of Case Medical Center at University Hospitals in Cleveland, found that patients lived an average of 18 additional months by turning on the stimulating device at least two hours a day. The only federally approved drug for ALS, Rilutek, offers modest hope with an added two months of life, according to studies on the drug.

Since Reeve's surgery in 2003, Onders has operated on 32 paralyzed patients with spinal cord injuries. Reeve was his third case, and the surgery helped him breathe on his own for many hours a day, said Onders, director of minimally invasive surgery at Case Medical Center. He said 97 percent of the paralyzed patients no longer needed their ventilators.

Carlo, 57, is hoping for similar success.

So is Augie Nieto, founder of Life Fitness, an equipment manufacturing company. The 49-year-old ALS patient from southern California was diagnosed in 2005. His surgery is scheduled for next month.

"It is important to be proactive," said Nieto, who started Augie's Quest to raise money for ALS research. Onder's technique, he said, "offers minimal risk with a maximum upside."

Ventilators can help patients breathe and live longer, but fewer than 10 percent of ALS patients in the United States elect to go on one.

Carlo is hoping that the new surgically implanted electrodes will keep his diaphragm strong for a longer period of time, and that he will push back death. "And maybe a treatment will come along before that," Carlo said this week.

ALS doctors at the Mount Sinai School of Medicine in Manhattan, Johns Hopkins and Stanford University medical centers and The Methodist Hospital in Houston also will be part of the clinical trial. The FDA has given the green light to implant and study the stimulating electrodes in 100 ALS patients.

Onders, an expert on the diaphragm, said the initial pilot study was not embraced at first. Only after he presented his data at several meetings, and to the FDA for permission to expand the trial, have ALS colleagues taken notice and joined in the collaboration.

"I am pleased to be part of this work," said Dr. Mark Sivak, an ALS doctor at Mount Sinai. "It will add tremendous quality of life to ALS patients." Mount Sinai doctors are awaiting hospital approval to do the surgery, which could begin there by May.

During the procedure, two electrodes and one grounding electrode are placed within the diaphragm. The electrodes are connected to a computer wire that is inserted through a small tube that protrudes from the chest wall. An external device turns on the stimulating electrodes. Patients use the device five times a day for 30 minutes at a time.

With a stronger diaphragm, the lungs are able to expand better and breathing is helped, Onders said. "We are not going to cure patients," he added. "This is just one muscle."

Treating ALS

A new surgical procedure could help to extend the life of patients suffering from amyotrophic lateral sclerosis, also known as Lou Gehrig's disease.

1. Two electrodes and one grounding electrode are inserted in the diaphragm.

2. Electrodes connect to a computer wire that is then inserted through a small tube that protrudes from the chest wall.

3. External remote control device turns on the stimulating electrodes. Patients are asked to use the device five times a day for 30 minutes at a time.

4. Stronger diaphragm enables lungs to expand better and breathe easier.

1 to 3 percent Amount of breathing ability ALS patients lose each month

$12,000 Approximate cost of device to aid breathing