This story recounts the experience of one individual who is receiving ITB TherapySM (Intrathecal Baclofen Therapy) for the treatment of severe spasticity. Medtronic invited this person to share her story candidly. The experiences noted here are specific to this particular person. As you read it, please bear in mind that the experiences are specific to this particular individual. Not everyone who receives ITB Therapy will receive the same benefits as the individual in this story. Talk with your doctor to determine if ITB Therapy is right for you.
Carol’s Story
Living with Severe Spasticity Due to Stroke
It was a six-year struggle for Carol to come back from the effects of a serious stroke. When she first returned home following three months of long-term care in a medical facility, she had a severely drawn up right foot and spasticity in her arm and leg.
Unable to walk because of her foot, Carol relied entirely on the wheelchair for her mobility.
“She couldn’t use her right arm, she couldn’t open her right hand at all,” her husband, Pete, recalls. “We kept trying to get her to do those things and she tried very hard, as much as she could.”
After two years, Carol was able to call Pete by his name. After three years, Pete and Carol met with a physician who suggested that Carol have her right Achilles tendon lengthened so her right foot wouldn’t be drawn up. He also recommended Medtronic ITB Therapy, also known as the baclofen pump, as a way to manage the spasticity on her right side.
Starting ITB Therapy
Carol had a screening test to see if ITB Therapy would help relieve her spasticity. The test was successful. She went on to have the pump and catheter surgically placed.
Carol’s procedure went well and she did not experience any complications. However, surgical complications, side effects of the drug, or both, can occur with ITB Therapy. 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.
“Once we got the baclofen pump, we started to see some changes,” Pete says. “Her hand started to move. She could open and close her hand. It took a period of time, of course, and her leg started to relax.”
Carol's Life Today
Today, Carol is able to walk and is enthusiastic about her progress. “I walk. And just realize I couldn’t do that before,” she says. “It is such a pleasure to be able to do it.”
Pete is always with Carol, but she is more independent than she was in the past. “I had to help her up almost every stair. I don’t now,” he says. “We walk out and sit on the bench and watch the cars go by and yell at those that go too fast… you know, the things that old folks do!”
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call
IMPORTANT SAFETY INFORMATION ON 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, 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, dizziness, respiratory depression (difficulty breathing), hypothermia, 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 Medtronic, Inc.
USA Rx Only Rev 0911
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
- Print Page
- E-mail Page
- A
- A
- A Text Size
Additional information
Take Charge
- Find a Doctor
- Talk With an Ambassador About ITB Therapy
- Learn about ITB Therapy from a patient who receives it
