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.

Ali's Story

Living with Spasticity

Ali was born 13 weeks premature. As an infant, she arched her back frequently, and her arms and legs became increasingly stiff. At 14 months of age, Ali was diagnosed with spastic quadriplegic cerebral palsy (CP).

As Ali grew, her parents Debby and Mark noticed increasing spasticity, especially on her left side. "I worried that I would break an arm or a leg when I dressed her," Debby says. Ali followed a daily regimen of stretching and motion exercises that would relieve her severe spasticity for a few hours. But the stiffness would always return.

Initial Treatments

Ali and her family considered a rhizotomy, a neurosurgery that selectively severs problem nerves in the spinal cord to relieve symptoms like Ali's. But with their doctor's help, they determined this procedure was not right for Ali. The doctor recommended they try a Medtronic baclofen pump (ITB Therapy).

How ITB Therapy Helped Ali

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.

Ali underwent a screening test to see if the liquid baclofen would relieve her symptoms. "The difference after the screening test was amazing," Debby recalls. She found Ali's arms and legs much easier to move.

Although Ali did experience some weakness, the test indicated she would be a good candidate for the therapy. Six weeks later, 5-year-old Ali had a pump surgically placed.

Risks of the Procedure

Ali 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.

"I Finally Feel Like I Have My Severe Spasticity under Control."

With her spasticity under control, Ali's independence grew. Her full-time health aide was reduced to part-time hours. At school, she was allowed to go to the cafeteria and music class without assistance. She even gained the dexterity to use a power wheelchair.

Since her original pump implant, Ali has had her pump replaced three times due to normal battery depletion. (Most pumps need to be replaced for this reason every 6 to 7 years.) During her first replacement, the catheter had not been primed with medication, leading Ali to experience additional spasticity until her physician detected and corrected the problem.

Ali graduated from high school and works as a courtesy clerk at a grocery store. She participates in drama and enjoys outdoor activities. "I finally feel like I have my severe spasticity under control," she says.

Next: Nick'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