About Cerebral Palsy
Living with cerebral palsy poses difficult physical challenges. One of these challenges is severe spasticity, which can get in the way of daily activities. Fortunately, there is a therapy from Medtronic that can minimize severe spasticity in some individuals.
Cerebral palsy is a movement and posture disorder resulting from an injury or defect to the developing brain (brain damage).
Cerebral palsy can be caused by brain injury during intrauterine life or at birth. It can also be acquired after birth. In this case, cerebral palsy is usually caused by brain damage in the first few months or years of life.
Several risk factors can increase the likelihood of cerebral palsy. However, it's important to know that these risk factors will not necessarily result in the disease.
These risk factors are usually present:
- During fetal development before, during, or shortly after birth
- During infancy
Risk factors for cerebral palsy include:1
- Premature birth
- Low birth weight
- Inability of the placenta to provide the developing fetus with oxygen and nutrients
- Lack of growth factors during intrauterine life
- RH incompatibility between mother and infant
- Infection of the mother with German measles or other viral diseases in early pregnancy
- Bacterial infection of the mother, fetus or infant that directly or indirectly attacks the infant's central nervous system
- Prolonged loss of oxygen during birth
- Severe jaundice shortly after birth
Early signs of cerebral palsy usually appear before a child is 18 months old. Infants with cerebral palsy are frequently slow to reach developmental milestones, such as learning to roll over, sit, crawl, smile, or walk. Parents are often the first to suspect that their infant is not developing motor skills normally.
A person with cerebral palsy may have one or more of the following effects:1
- Muscle tightness or spasticity
- Disturbance in gait or mobility
- Involuntary movement
- Difficulty swallowing and speaking
Cerebral palsy ranges from mild to severe. People with cerebral palsy often have other conditions related to developmental brain abnormalities, such as intellectual disabilities, vision and hearing problems, or seizures.2
Cerebral palsy is usually diagnosed early in life. Your doctor will review your medical and family history and perform a physical evaluation. In addition to checking for the typical symptoms, the doctor may perform specialized tests to help diagnose your condition. Your doctor can help distinguish normal variation in development resulting from a developmental disorder.
About Spasticity Due to Cerebral Palsy
Spasticity is caused by damage or injury to the part of the central nervous system (the brain or spinal cord) that controls voluntary movement. This damage disrupts important signals between the nervous system and muscles, creating an imbalance that increases muscle activity or spasms.
Spasticity can make one's movement, posture, and balance difficult. It may affect your ability to move one or more of your limbs, or to move one side of your body. Sometimes spasticity is so severe that it gets in the way of daily activities, sleep patterns, and caregiving. In certain situations, this loss of control can be dangerous for the individual.
- Cerebral Palsy Fact Sheet. United Cerebral Palsy. http://www.ucp.org/uploads/media_items/cerebral-palsy-fact-sheet.original.pdf. Accessed October 15, 2012.
- Cerebral Palsy Definition. Mayo Clinic. www.mayoclinic.com/health/cerebral-palsy/DS00302. Accessed October 15, 2012.
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.
IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen 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.
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 0913
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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.
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