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Welcome to the website of the
Southwest Virginia MS Support Group
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Intrathecal Baclofen Pump (ITB
Therapy)
SOURCE: Multiple Websites as seen below
Description
Baclofen whether Oral or IT acts on the central nervous system to relieve spasms, cramping, and tightness of muscles caused by spasticity in multiple sclerosis. Intrathecal baclofen therapy (ITB) consists of long-term delivery of
baclofen
to the intrathecal space in the spinal column. It is used in MS for those individuals with severe spasticity whose symptoms are not sufficiently relieved with oral baclofen and other oral medications. Because ITB is administered directly in to the intrathecal space, it provides better spasticity reduction at lower doses than can be achieved with oral medications that, at higher doses, can produce sedation, sleepiness, and imbalance.
Proper Usage
Individuals who are considered candidates for intrathecal baclofen are given a test dose via lumbar puncture. Those who respond positively to the test dose can be considered for ongoing ITB therapy.
The
SynchroMed® Infusion System consists of: a small titanium disk, about three inches in diameter and one inch thick, which contains a refillable reservoir for the liquid; a computer chip that regulates the battery-operated pump; and a flexible silicone catheter that serves as the pathway from the pump to the intrathecal space.
Implantation of the pump requires two incisions, one in the lower abdomen to create a pocket for the pump, and another one in the lower back for inserting the catheter that is looped around the torso, inside the body, connecting the pump to the intrathecal space.
The dose of medication delivered by the pump is programmed and subsequently adjusted if necessary by non-invasive radio-telemetry. The pump is refilled every 4 to 12 weeks by injection in a procedure lasting about 20 minutes.
To prevent the baclofen supply from running out, the pump contains a programmable alarm that sounds whenever the reservoir need to be refilled, the battery is low, or the pump is malfunctioning in some way.
In the event that the alarm sounds, you should contact your physician immediately.
Precautions
As with any surgical procedure, the implantation of the pump carries with it the risk of infection and the risks associated with general anesthesia. There is an additional risk of spinal fluid leakage.
Your doctor should check your progress at regular visits, especially during the first few weeks of treatment with this medicine. During this time, the amount of medicine you are using may have to be changed often to meet your individual needs.
Make sure to keep all appointments to refill the pump. If the pump is not refilled on time you may experience return of your muscle tightness and early withdrawal symptoms that might include: itching of the skin; decreased blood pressure; blurred vision*; confusion; dizziness; faintness or lightheadedness when rising from a lying or sitting position; sweating; unusual tiredness or weakness*; burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feelings*; seizures.
Abruptly stopping intrathecal baclofen can result in serious medical problems and in rare cases has been fatal.
Possible Side Effects
Side effects that typically go away as your body adjusts to the medication and do not require medical attention unless they continue for several weeks or are bothersome: drowsiness or unusual tiredness*; increased weakness*; dizziness or lightheadedness; confusion; unusual constipation*; new or unusual bladder symptoms*; trouble sleeping; unusual unsteadiness or clumsiness*.
Unusual side effects that require immediate medical attention: high fever; altered mental status; spasticity than is worse than was experienced prior to starting ITB Therapy; muscle rigidity.
Symptoms of overdose: drowsiness; lightheadedness; sudden onset of blurred or double vision*; shortness of breath or troubled breathing; vomiting; seizures; loss of consciousness; coma.
*Since it may be difficult to distinguish between certain common symptoms of MS and some side effects of baclofen, be sure to consult your health care professional if an abrupt change of this type occurs.
SOURCE:
http://my.ClevelandClinic.org
Spasticity is a motor disorder characterized by
tight or stiff muscles that may interfere with voluntary
muscle movements. Baclofen is a muscle relaxant medication. It
is commonly used in adults to decrease Spasticity related to
spinal cord injuries or multiple sclerosis.
Baclofen is also
used to treat children who have cerebral palsy.
How does baclofen work?
Spasticity is caused by an imbalance of excitatory and
inhibitory input in the spinal cord. This imbalance causes
hyperactive muscle stretch reflexes. These reflexes result in
involuntary spasms and increased muscle tone.
Baclofen works by blocking the release of excitatory
neurotransmitters in the spinal cord. Ideally, baclofen
restores the balance of excitatory and inhibitory input to
reduce muscle hyperactivity. In this way, it also allows more
normal motor movements.
Why is intrathecal baclofen preferred over oral
baclofen?
Baclofen can be taken orally (by mouth in pill form) or
delivered intrathecally (as an injection in the spine). Oral
baclofen causes side effects that may limit its usefulness,
especially when prescribed for children. Of the oral baclofen
delivered throughout the body, only a small portion goes to
the spinal fluid where it is needed to work.
With an intrathecal delivery system, baclofen is delivered
right to the target site in the spinal cord. Because the
intrathecal system continuously delivers baclofen in small
doses directly into the spinal fluid, there are fewer and less
severe side effects than that seen with the oral medication.
What is the baclofen pump system?
The baclofen pump system is the intrathecal (directly into
the spinal fluid) method of delivering the medication. The
system consists of a catheter (a small, flexible tube) and a
pump. The pump--a round metal disc, about one inch thick and
three inches in diameter--is surgically placed under the skin
at the level of the abdomen.
The pump stores and releases prescribed amounts of
medication through the catheter. The pump has a 10-mL fluid
capacity and can be refilled by inserting a needle through the
skin into a filling port (called the diaphragm) in the center
of the pump.
Who is a candidate for the pump system?
Anyone who has spasticity and weighs over 30 pounds can be
considered for the baclofen pump system. The pump system is
appropriate when adjustable and potentially reversible
treatment is desired, but cannot be achieved with oral
medication.
How will my doctor know if the baclofen pump system
will work?
If your doctor recommends the baclofen pump system, you
will have a trial of the intraspinal therapy to test the
potential effectiveness of the medication. During the
medication trial, a small needle is placed near the spinal
cord in the lower back. The medication is injected into the
spinal canal and you are assessed over 8 to 10 hours to
determine how well the medication treats the spasticity. If
your muscles don't relax during the first trial, a larger dose
may be given the next day to determine its effectiveness.
This procedure causes minor discomfort. You may experience
temporary muscle weakness due to the relaxing effect of the
medication. This is caused by receiving a large dose of
medication all at once during the trial.
Patients who experience positive results with the
intrathecal medication can decide with their doctor if they
should have a baclofen pump system implanted.
How is the pump system implanted?
The pump is surgically placed just underneath the skin,
usually in the lower abdominal area. The procedure to place
the pump lasts from 1 ½ to 2 hours.
The procedure may be performed under local anesthesia
(pain-relieving medication that numbs the area while you
remain awake) or general anesthesia (medication given by an
anesthesiologist that induces sleep). Children are most often
given general anesthesia and are asleep for the entire
procedure.
The catheter is inserted through a needle and guided into
the spinal canal, close to where pain pathways enter the
spinal cord.
The other end of the catheter is tunneled under the skin
to the abdomen, where a pocket is created. There, the pump is
implanted through an incision in the abdomen, anchored to
surrounding tissue, and connected to the catheter. Once the
incision is closed, the pump reservoir is filled with the
dosage of baclofen prescribed by the physician.
How is the medication dispensed?
With a programmable pump, a tiny motor moves the
medication from the pump reservoir through the catheter.
Baclofen flows freely through the spinal fluid, affecting the
nerves to control muscle hyperactivity.
Adjustments in the dose, rate, and timing of the
medication can be made by your doctor, using an external
programmer. The pump system can be set to dispense medication
continuously or at certain times of the day. The pump can also
be easily reprogrammed if necessary.
Patients must return to their doctor's office for pump
refills and medication adjustments, typically every 2 to 3
months. The pump system is taken out and replaced at the end
of the battery's life span (which is usually 3 to 5 years).
What are the side effects of baclofen?
Some side effects of baclofen include dizziness,
drowsiness, headache, nausea and weakness. Problems with the
infusion pump can cause either overdose or sudden withdrawal
of baclofen.
What are the potential advantages of the baclofen pump
system?
Typically, the intrathecal baclofen pump:
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Effectively reduces spasticity and involuntary spasms,
promoting a more active lifestyle, better sleep, and reduced
need for oral medications.
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Continuously delivers baclofen in small doses directly
to the intraspinal fluid, increasing the therapeutic
benefits and causing fewer and less severe side effects than
that seen with the oral medication.
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Can be individually adjusted to allow infusion rates
that vary over a 24-hour period. It can be turned on or off
or programmed to infuse different levels of medication
throughout the day, depending on your needs. For example,
people who find their spasticity helpful in maintaining leg
extension for standing or walking can have a lower infusion
rate during the day.
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Can be turned off if spasticity reduction has shown no
benefit.
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© Copyright 1995-2008 The Cleveland Clinic Foundation. All
rights reserved
The Intrathecal Baclofen Pump is made of
Titanium, the Medtronic's pump is an intrathecal drug delivery
device capable of extremely sophisticated titration of dosage
to 1/1000 of a microgram. Drugs are delivered continuously
24/7. Pump has the capacity to store approximately 6 months
supply of the drug.
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Baclofen, whether used
Baclofen-Oral or
Baclofen-IT
by Intrathecal Baclofen Therapy, is a medication commonly used to decrease
spasticity related to multiple sclerosis, spinal cord injuries,
or other neurological diseases.
Spasticity is a muscle problem characterized by tight or
stiff muscles that may interfere with voluntary muscle
movements.
How Does Baclofen Work?
Normally muscles receive electrical signals via nerves to
contract and relax. Spasticity is caused by an imbalance of
electrical signals coming from the spinal cord through the
nerves to the muscle. This imbalance causes the muscle to become
hyperactive, resulting in involuntary spasms. Baclofen works by
restoring the normal balance and reducing muscle hyperactivity.
In this way, it allows for more normal muscle movements.
What Are the Side Effects of Baclofen Therapy?
Side effects may include:
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Dizziness
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Drowsiness
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Headaches
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Nausea
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Weakness
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What Is Intrathecal Baclofen?
Baclofen can be taken orally as a pill or delivered directly
into an area of the spine called the intrathecal space. The
intrathecal space contains the cerebrospinal fluid -- the fluid
surrounding the spinal cord and nerve roots. Often MS patients
receive intrathecal baclofen because oral baclofen causes
unpleasant side effects, such as confusion, weakness, and
sleepiness. But intrathecal baclofen delivers the drug right to
the target site in the spinal cord. Since the medication does
not circulate throughout the body, only tiny doses are required
to be effective. Therefore, side effects are minimal.
What Is the Intrathecal Baclofen Pump System?
The intrathecal baclofen pump system is the way doctors give
the drug directly into the spinal fluid. The system consists of
a catheter (a small, flexible tube) and a pump. The pump -- a
round metal disc, about one inch thick and three inches in
diameter -- is surgically placed under the
skin of the abdomen near the waistline.
The pump stores and releases prescribed amounts of medicine
through the catheter. With a programmable pump, a tiny motor
moves the medication from the pump reservoir through the
catheter. Using an external programmer, your treatment team can
make adjustments in the dose, rate, and timing of the
medication.
People with the pump must return to their doctor's office
for pump refills and medication adjustments, typically every 1-3
months. The pump is taken out and replaced at the end of the
battery's life span (which is usually 5 to 7 years).
Who Is a Candidate for the Intrathecal Baclofen Pump?
Anyone who has spasticity that is not responsive to oral
treatment is a candidate.
If you are considering intrathecal baclofen therapy, you
will generally meet with a treatment team that may include a
doctor specialized in rehabilitation (physiatrist), a
physical therapist, an
occupational therapist, a nurse, and a social worker. All of
these professionals work as a team to provide a comprehensive
evaluation of your spasticity symptoms and to establish a
treatment plan adapted to your personal needs.
SOURCE:
www.medtronic.com
Explore ITB Therapy
ITB TherapySM (Intrathecal Baclofen Therapy)
delivers a liquid form of baclofen, Lioresal®
Intrathecal (baclofen injection), directly into the intrathecal
space where fluid flows around the spinal cord. ITB Therapy may
relieve severe spasticity with small amounts of Lioresal
Intrathecal delivered via a programmable pump that is surgically
placed and connected to a catheter in the body. Because the drug
is delivered directly to where it is needed in the spinal fluid,
it does not circulate throughout the body in the blood. This may
help minimize potential side effects that often accompany oral
baclofen.
Pump
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and
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Catheter
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ITB Therapy has been shown in studies to significantly reduce
spasticity.1-3
There have been reports that ITB Therapy helped people be more
independent, allowing them to feed or dress themselves, sit more
comfortably, or transfer more easily.3-8
Caregivers also reported satisfaction with ITB Therapy.8,
9
Learn whether this therapy may be right for you or someone in
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, traumatic 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 one 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,
respiratory depression (difficulty breathing), 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,
diathermy, etc.
Lioresal® is a registered trademark of Novartis
Pharmaceuticals Corporation
SOURCE:
en.wikipedia.org
An intrathecal pump is a medical device used to delivery
very small quantities of medications directly to the
spinal fluid of a human being. Medications such as
Baclofen-IT
baclofen,
morphine, or ziconotide may be delivered in this manner to
minimize the side effects often associated with the higher
dosages commonly found in oral medications of the same type.
People with
spastic diplegia or other forms of
spasticity, or people in intolerable
pain and nociception, who cannot tolerate side effects of
the higher-dose oral medications of the same medication type,
are potential candidates for that medication being administered
via an intrathecal pump.
The intrathecal pump consists of a metal
pump which stores and delivers the medication, and a
catheter which delivers the medication from the pump to the
intrathecal space in the spine where the medication takes
effect. Two types of pumps are available: a constant rate pump
delivers the medication at a constant rate, and a programmable
pump delivers the medication according to a rate determined by a
programmable computer program. Currently only Medtronic
manufactures programmable intrathecal pumps in the United
States.
The implantable medical device requires a surgical
procedure; a
surgeon usually performs a trial intrathecal injection or a
temporary intrathecal pump to determine if the medication works
to begin with, and thus if a pump is appropriate. A permanent
intrathecal pump is then implanted if the patient derives at
least 50% improvement in his or her symptoms.
Possible complications
Possible complications from the implantation (though these
are relatively rare now if the surgery is done correctly)
include infection and excessive bleeding during the surgery,
spinal cord injury during the surgery, catheter fracture or
migration, and in extremely rare cases, death during the surgery
or from withdrawals or overdose from medication.
Links
References
Penn, RD et al. (1989).
"Intrathecal baclofen for severe spinal spasticity". New Engl
J Med 320: 1517-1521.
PMID 2657424.
More about the Intrathecal Baclofen Pump
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