Benefits and Risks – ITB Therapy

Although Medtronic ITB Therapy^SM (Intrathecal Baclofen Therapy) won’t eliminate the primary source of your condition or severe spasticity, it may help you manage the tight, stiff muscles that make daily living more difficult for you.

Benefits of ITB Therapy

ITB Therapy, also called the baclofen pump, has been shown to benefit people who have been affected by cerebral palsy, brain injury, stroke, multiple sclerosis, and spinal cord injury in the following ways:

Multiple studies show it significantly reduces spasticity^1-9 and spasms.^2,7
There have been reports that ITB Therapy has helped people be more independent, allowing them to feed or dress themselves, sit more comfortably, or transfer more easily.^10.11
Some studies have reported caregiver satisfaction with ITB Therapy.^10,12

For people whose spasticity is of cerebral origin (cerebral palsy, brain injury, or stroke):

A study found that ITB Therapy may provide long-term control of spasticity in people living with cerebral palsy or brain injury.⁶
A number of studies have determined ITB Therapy reduces spasticity in both the upper and lower limbs of those living with cerebral palsy, brain injury, and stroke.^2,3,13-15

For people whose spasticity is of spinal origin (multiple sclerosis or spinal cord injury):

A study showed that ITB Therapy may provide long-term control of spasticity⁵
A retrospective chart review of 20 subjects revealed ITB Therapy may improve function.¹⁶

Dr. Stephen Koelbel, a physical medicine and rehabilitation specialist near Boston, MA, describes the level of relief that ITB Therapy has provided to the patients he has treated.

Risks Associated with 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 (intrathecal baclofen) and to understand the early symptoms of baclofen withdrawal. Some people are at more risk than others for baclofen withdrawal; consult with your doctor.

Dr. Stephen Koelbel describes some of the risks and complications associated with the use of the baclofen pump and catheter.

Side effects associated with ITB Therapy (the baclofen pump) usually are temporary and can be managed by adjusting the dosage of intrathecal baclofen (the drug contained in the pump).

The most common side effects include:

Loose muscles
Sleepiness
Upset stomach
Nausea/vomiting
Headache
Dizziness

Pump failure may cause an overdose or underdose of intrathecal baclofen. The signs and symptoms of an overdose include:

Drowsiness
Lightheadedness
Difficulty breathing
Seizures
Loss of consciousness or coma

The signs and symptoms of an underdose include:

Increase or return of spasticity
Itching
Low blood pressure
Lightheadedness
Tingling sensation

Following are possible device complications:

The catheter or pump could move within the body or push through the skin.
The pump could stop because the battery has run out or because of component failure.
The catheter could leak, tear, kink, or become disconnected resulting in an underdose or abrupt cessation of intrathecal baclofen. An abrupt stop of intrathecal baclofen can lead to:
- High fever
- Altered mental status
- Returned spasticity
- Muscle rigidity
- Death, in rare cases

It is important to note that the pump will sound an alarm when the pump needs to be replaced, filled with baclofen, or if there is a problem with the pump.

Always inform a healthcare professional that you have an implanted infusion system before any medical or diagnostic procedure (e.g., MRI, diathermy, etc.).

For more information, please read the Lioresal^® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed^® Infusion System Information.

Why should I choose a Medtronic device over another option?

When choosing a device to manage your severe spasticity symptoms, look to a healthcare company that understands your condition and has extensive experience offering safe and effective therapies.

Here are some important facts for you to consider:

Medtronic has more intrathecal therapy experience than any other company
Medtronic ITB Therapy is the only intrathecal therapy backed by 20 years of severe spasticity management experience
Explore the proven benefits of Medtronic ITB Therapy
More than 60,000 Medtronic SynchroMed^® pumps have been implanted worldwide for Medtronic ITB Therapy
For more than 15 years Medtronic has collaborated with numerous advocacy groups to help raise awareness of spasticity and the conditions that can cause it
Medtronic is the only company to track product performance, including more than 17,000 neurological devices and more than 6,100 patients
Your Medtronic infusion system can be programmed and refilled in clinics across the United States and around the word

References:

Francisco GC, Boake C. Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study. Arch Phys Med Rehabil. 2003;84(8):1194-1199.
Meythaler JM, Guin-Refroe S, Brunner RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.
Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006;87(11):1509–1515.
Gilmartin R. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15(2):71-77.
Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240.
Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003;98(2):291-295.
Coffey RJ, Cahill D, Steers W. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993;78(6):226-232.
Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromodulation. 2002;5(1):16-24.
Becker R, Alberti O, Bauer BL. Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury. J Neurol. 1997;244(3):160-166.
Krach LE, Nettleton A, Klempka B. Satisfaction of individuals treated long-term with continuous infusion of intrathecal baclofen by implanted programmable pump. Pediatr Rehabil. 2006 Jul-Sep; 9(3):210-218.
Stempien L, Tsai T. Intrathecal baclofen pump use for spasticity: a clinical survey. Am J Phys Med Rehabil. 2000;79(6):536-541.
Campbell WM, Ferrel A, McLaughlin JF, et al. Long-term safety and efficacy of continuous intrathecal baclofen. Dev Med Child Neurol. 2002;44(10):660-665.
Meythaler JM, Guin-Renfroe S, Grabb P, Hadley MN. Long-term continuously infused intrathecal baclofen for spastic-dystonic hypertonia in traumatic brain injury: 1-year experience. Arch Phys Med Rehabil. 1999;80(1):13-19.
Francisco GE, Hu MM, Boake C, Ivanhoe CB. Efficacy of early use of intrathecal baclofen therapy for treating spastic hypertonia due to acquired brain injury. Brain Injury. 2005;19(5):359-364.
Meythaler JM, Guin-Renfroe S, Law C, Grabb P, Hadley MN. Continuously infused intrathecal baclofen over 12 months for spastic hypertonia in adolescents and adults with cerebral palsy. Arch Phys Med Rehabil. 2001;82(2):155-161.
Dario A, Scamoni C, Bono G, Ghezzi A, Zaffaroni M. Functional improvement in patients with severe spinal spasticity treated with chronic intrathecal baclofen infusion. Funct Neurol. 2001;16(4):311-315.

Next: Questions and Answers

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.

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.

Last updated: 20 Feb 2013