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.

Brian's Story

Living with Spasticity

Despite being born with spastic quadriplegic cerebral palsy (CP), Brian did not let his disability rule his life.

"Growing up, people would say, 'You can't do this, or you can't do that.' But I never believed them," Brian says. "I knew that there was a lot more out there for me."

As Brian grew older, he had less and less control over his muscles and balance. Spasticity, or uncontrolled muscle contractions, made it increasingly difficult or impossible to perform many activities.

Brian was certain he could accomplish a lot with his life, but knew he needed to address his severe spasticity and motor control difficulties first.

Initial Treatments

Oral spasticity medications left Brian feeling groggy and did not adequately relieve his symptoms. After trying several different doses, Brian’s clinician told him about a Medtronic baclofen pump (ITB Therapy).

How ITB Therapy Helped Brian

ITB Therapy (Intrathecal Baclofen Therapy) relieves severe spasticity by 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 area where fluid flows around the spinal cord, called the intrathecal space.

Brian first needed a screening test to see if the liquid baclofen would relieve his symptoms.

"My spasticity was nearly gone during the trial!" Brian remembers. For 4 days after the trial he experienced a severe headache, which resolved on its own.

Risks of the Procedure

After having the pump surgically placed, Brian was sick and nauseous for several days and couldn't eat any food. After a few more days in the hospital, his muscles were looser and more relaxed.

Brian didn't experience any additional complications with his surgery. However, some people do experience surgical complications, other 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.

Accomplishing More

Since his pump was placed in 2006, Brian has noticed a dramatic increase in his independence, happiness, and quality of life. He is now able to care for his personal needs and transfer to and from his wheelchair. Relying less on other people for assistance, he feels much better about himself.

Brian is able to live on his own in an apartment to which only minor modifications have been required. A specialist in evaluation and training for assistive technology, Brian is also actively engaged as a board member in several nonprofit organizations. He has dedicated his life to advancing the independence of people with disabilities, at home and abroad.

“Whenever somebody who didn’t believe in me sees me now, I don't need to say anything,” he continues. “They see how fluidly I move and everything I've accomplished, and that says it all.”

Brian wants us to remember, “I have Cerebral Palsy; Cerebral Palsy does not have me.”

Next: Kaleigh's Story

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