Doctor and patient discuss the patient's condition

Evaluation and Trial

Severe Spasticity

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 clinical response to the intrathecal baclofen trial.
  • Are experiencing inadequate results or intolerable side effects with oral baclofen (when the severe spasticity is associated with multiple sclerosis or spinal cord injury).
  • 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 spasticity specialist. Most doctors who specialise in spasticity treatment are neurologists or doctors of physical medicine and rehabilitation.

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 trial.

ITB Trial

The trial can help determine whether you will respond to ITB Therapy. But that isn’t the only reason to have the test. The trail 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.


What is the ITB trial?

Your doctor will talk with you about the benefits and risks of the trial. 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 trial if you have an infection or are allergic to baclofen.

The trail may be done in a hospital. Your doctor will tell you how to prepare for the test, including instructions on your oral antispasticity medications.

During the trial, 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 trial may repeated at higher doses up to two additional times on different days.

It is important to know that the trial dose will affect you differently than the doses you receive during ongoing ITB Therapy, as those doses will be adjusted and customised to your needs over time.

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 trial dose is reducing your level of spasticity. Keep in mind, however, that what you experience during the trial 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 physiotherapy 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 trial.1 In a second clinical study, intrathecal baclofen reduced spasticity in 94% of individuals with spasticity of cerebral origin during the trail.2

Setting Treatment Goals

It’s important to have realistic expectations about treatment with a baclofen pump. With your doctor, make a list of goals you may achieve through this therapy. Here are some examples of possible treatment goals, depending on your individual situation:

  • Improve my range of motion.
  • Have fewer cramps and spasms.
  • Reduce pain.
  • Cut down on oral baclofen if it makes me confused or sleepy.
  • Make sitting more comfortable.
  • Make transfers easier.
  • Improve my balance.
  • Be less tired.
  • Walk further.
  • Get dressed, wash, or eat more easily.


Setting treatment goals


References

1

Penn RD, Intrathecal Baclofen for Spasticity of Spinal Origin: Seven Years of Experience. J Neurosurg, 1992, 77: 236-240.

2

Gilmartin R, Bruce D, et al. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol 2000; 71-77.


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.


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.