This story reflects the experience of one individual who is receiving Medtronic ITB Therapy^SM (Intrathecal Baclofen Therapy) for the treatment of severe spasticity. Medtronic, Inc. invited this person to share this story candidly. As you read it, please bear in mind that the experiences are specific to this particular individual. Results vary; not every response is the same.

Nick's Story

Nick, living with cerebral palsy

Living with Spasticity

From the time Nick was diagnosed with a developmental disorder that was later confirmed as cerebral palsy, his mother Eve had been actively researching treatment options.

Nick suffers from spastic quadriplegia, but he's always been determined to walk independently. So Eve found a physical therapist and a physical medicine and rehabilitation specialist that they both liked. Despite the therapy, Nick began experiencing spasticity-related pain, and his physical condition worsened.

"He would get into a crouch position and not be able to move," says Eve. "We were up every night with muscle cramps and charley horses." Until then, Nick had been mobile with a walker, but Eve worried that he would soon have to go back to using a wheelchair. Eve talked with Nick's therapists, who recommended a Medtronic baclofen pump (ITB Therapy). After a successful screening test, the family made plans to go ahead with the implant.

How ITB Therapy Helped Nick

ITB Therapy (Intrathecal Baclofen Therapy) relieves severe spasticity using a programmable pump placed just under the skin of the abdomen. The pump is connected to a flexible catheter that delivers a liquid form of baclofen directly into the body's "intrathecal space," where fluid flows around the spinal cord.

The improvement in Nick's severe spasticity was apparent as soon as he awoke from the implantation procedure. "In the hospital, he lifted his arms over his head for the first time in his life," Eve recalls.

Since the surgery, Nick has experienced a significant change in his level of physical functioning and the pain associated with his spasticity. "We're rarely up in the middle of the night with muscle cramps anymore," says Eve. "Nick walks with his walker at school. Wherever we go, he's mobile."

Risks of the Procedure

Nick didn't experience any complications with his surgery. However, some people do experience surgical complications, side effects of the drug, or both. As with any surgical procedure, there are risks associated with ITB Therapy. Some of these risks include meningitis, spinal fluid leak, infection, paralysis, headache, swelling, bleeding, and bruising. Drug-related side effects may include loose muscles, drowsiness, nausea/vomiting, headache, and dizziness.

"It's Made Such a Difference in My Child's Life."

To maintain the therapy, Nick's physical medicine and rehabilitation specialist refills his pump every three months. Once a year, the family meets with their pediatric neurosurgeon for a checkup.

As she reflects on her family's experience with a Medtronic baclofen pump, Eve says, "I understand how frightening the prospect of surgery can be. I also know the difference it has made in my child's life. He's doing so many things now that he may not have been able to do without this opportunity."

These days, Nick takes part in a weekly fitness program at his physical therapy center that includes swimming, weight lifting, and treadmill exercises. Although Nick doesn’t do a lot of independent walking, he functions well with his pump and learned to swim following the implant procedure.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Safety Information – ITB Therapy

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, traumatic brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait 1 year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.

The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, respiratory depression (difficulty breathing), seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced or if there is a problem with the pump. Always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.

For more information, please read the Lioresal^® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.

This therapy is not for everyone. Please contact your doctor. A prescription is required.

Lioresal^® is a registered trademark of Novartis Pharmaceuticals Corporation.

This story reflects one person's experience. Not every person will receive the same results. Talk to your doctor about your treatment options.

Last updated: 11 Dec 2008