This story reflects the experience of one individual who is receiving Medtronic ITB TherapySM (Intrathecal Baclofen Therapy) for the treatment of severe spasticity. Medtronic 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. Not everyone who receives ITB Therapy will receive the same results as the individual in this story. Talk with your doctor to determine if ITB Therapy is right for you.
Diagnosed with spasticity and cerebral palsy when she was 15 months old, Kaleigh has a can-do attitude that inspires everyone she meets.
"She has an awesome personality," her mother Julie says. "I've had perfect strangers come up to me and say, 'Your daughter just brightened my day.'"
As Kaleigh grew, her spasticity worsened. She walked arched over on her tiptoes, and her mum occasionally needed to carry her.
To treat her severe spasticity, Kaleigh tried a year of injection therapy and casting, but didn't get the relief she hoped for. Julie began searching for alternative options and decided to ask Kaleigh's clinician about ITB Therapy (a Medtronic baclofen pump).
ITB 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.
Kaleigh first needed a trial to see if the liquid baclofen would relieve her symptoms. After the trial, "Kaleigh's muscles were like limp noodles," Julie recalls. "I was excited, but Kaleigh was a little scared. She'd never been able to move that much without feeling pain."
As the medication wore off, Kaleigh experienced cramping in her legs. Several hours later, her muscles were back to the way they were before the trial. They decided to go forward with the surgical procedure so Kaleigh could receive ITB Therapy.
Kaleigh didn't experience any complications with her surgery. However, some people do experience surgical complications, side effects of the drug, or both. There are risks associated with ITB Therapy. Some of these risks include pain, 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.
Since receiving ITB Therapy, Kaleigh has found that she no longer needs crutches when walking short distances. Her gait and posture have also improved, and she's gained enough dexterity to play the piano.
Julie loves the independence that the pump has given her daughter. Kaleigh no longer needs to be carried and enjoys walking in stride with her friends and family.
"I like being able to jump rope and do other hard stuff," Kaleigh says. "Now I can walk better and I don't need Mummy there to make sure I don't fall!"
The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs 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 know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.
People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.
The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), 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. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. 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. You or your caregiver should always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.
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.