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.

Alexis's Story

Living with Spasticity

Alexis was born with spastic quadriplegic cerebral palsy. Through her first 6 years of life she had trouble expressing herself due to severe spasticity.

When Alexis attempted to write, spasticity prevented her from making a single mark on a piece of paper. When she tried to speak, the spasticity constricted her voice.

Her communication limitations made it hard for others to get to know Alexis. “I would tell everyone how smart and fun Alexis was,” recalls her mother, Rachel. “But I think I was the only one who realized it at that point.”

Initial Treatments

Alexis, her mother, and her care team tried several treatments for the spasticity, such as oral baclofen and injection therapy. At one point, Alexis was at the maximum dose of the oral medication and every 3 months she received over 30 painful injections.

The treatments made Alexis feel awful and her spasticity was still out of control. That’s when her doctor told her about a Medtronic baclofen pump (ITB Therapy).

How ITB Therapy Helped Alexis

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.

Alexis had a screening test to see if the liquid baclofen would relieve her symptoms. “The screening test went perfectly. We decided to have the pump placed the next day,” Rachel recalls.

Risks of the Procedure

Alexis didn’t experience any complications with her 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.

Opening New Doors

Over time, Rachel noticed that Alexis was able to sit much straighter in her wheelchair. Her speech drastically improved, and Alexis even began drawing pictures.

“She eventually gained enough muscle control to operate a power wheelchair,” Rachel recalls.

The Medtronic baclofen pump also helped Alexis discover that she loves outdoor activities like riding roller coasters, swimming, and horseback riding. She gained enough independence to enroll in mainstream school.

"ITB Therapy has opened so many new doors for Alexis," Rachel says. "Now everyone who meets her knows what a wonderful little girl she is."

"Getting this pump for my daughter was the best decision that I have ever made."

Next: Ali'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