Evaluation and Screening Test
Since 1992, more than 60,000 Medtronic baclofen pumps have been used worldwide to manage severe spasticity related to a variety of conditions. Talk to your doctor about a spasticity evaluation and screening test to see if the therapy may be right for you or your loved one.
When to Consider ITB TherapySM
Consider whether ITB Therapy may be right for you or your loved one if:
- Spasticity, spasms, or pain is interfering with function, care, positioning, or daily activities
- Oral baclofen isn't working well enough or has intolerable side effects such as fatigue or constipation
Eligibility Requirements
Your doctor will consider many important factors to decide if ITB Therapy is right for you. You may be a candidate for ITB Therapy if you:
- Have severe spasticity that is interfering with your function, care, comfort, or daily activities.
- Show a positive response to the ITB screening test.
- Are experiencing inadequate results or intolerable side effects (such as fatigue or nausea) with oral baclofen.
- Had the injury causing your spasticity at least 1 year ago (traumatic brain injury only).
- Are large enough for an implanted pump.
- Are not allergic to baclofen.
- Do not have any infection.
Spasticity Consultation
To explore whether ITB Therapy may be right for you, first ask for an evaluation of the spasticity you are experiencing. Your doctor may conduct the evaluation or refer you to a neurologist or physiologist who specializes in spasticity treatment. A spasticity consultation usually includes:
- A questionnaire
- A medical history
- An examination
- Standard spasticity assessments
You will meet with your doctor to talk about the results, your goals, and treatment options. If you are a candidate for ITB Therapy, the next step is a screening test.
ITB Screening Test
The screening test for ITB Therapy can help determine whether you will respond to ITB Therapy. But that isn’t the only reason to have the test. The screening test also provides information on your muscle strength and movement control. You and your doctor can use this information to develop a treatment plan that is right for you.
Your doctor will talk with you about the benefits and risks of the screening test. Common and/or serious side effects of the screening test include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. You should not have the screening test if you have an infection.
The screening test may be done in a hospital or doctor’s office. Your doctor will tell you how to prepare for the test, including instructions on your oral antispasticity medications.
During the test, a dose of intrathecal baclofen is injected into the space surrounding the spine. The effects are then evaluated throughout the course of a day. The results are positive if your spasticity is significantly reduced, as shown by specific spasticity evaluations and improved range of motion. The test may be repeated one or two times at higher doses of baclofen if needed for a complete assessment.
It is important to know that the screening test dose will affect you differently than the doses you receive during ongoing ITB Therapy, as those doses will be adjusted and customized to your needs.
If you are usually able to walk, you may not be able to during all or part of the test. This is considered a positive result because it means the test dose is reducing your level of spasticity. Keep in mind, however, that what you experience during the test will be different than what you experience during ongoing ITB Therapy. During the first months of receiving ITB Therapy, your dose will be gradually adjusted while you participate in physical therapy to develop new gait patterns and get stronger. That way, you can take advantage of any spasticity that has been helping you to walk until you are strong enough to walk without it.
In one clinical study, intrathecal baclofen reduced spasticity in 97% of people with severe spasticity due to multiple sclerosis or spinal cord injury during the screening test.1 In a second clinical study, intrathecal baclofen reduced spasticity in 94% of individuals with spasticity of cerebral origin during the screening test.2
If You Are a Candidate
Here are some suggestions to help you decide if ITB Therapy is right for you:
- Read personal stories or talk with people who have a baclofen pump
- Talk with a patient who already receives ITB Therapy and has volunteered to share his or her experience and answer your questions
- Make sure you’re comfortable with your doctor. He or she should be helpful, supportive, and ready to answer any questions you may have.
- Request more information from Medtronic
- Carefully weigh the benefits and risks of ITB Therapy
- Consider the Full Prescribing Information
Before you meet with your doctor, think about what you hope to learn. Prepare questions, and be ready to provide information about your medical history.
References
- Penn RD, Intrathecal Baclofen for Spasticity of Spinal Origin: Seven Years of Experience. J Neurosurg, 1992, 77: 236-240.
- Gilmartin R, Bruce D, et al. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol 2000; 71-77.
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
