FYI - Baclofen Pump Info-study

RCookHook(AT)aol.com
Tue, 2 Mar 1999 15:36:03 EST

This article is from the Pushin' On Newsletter, Vol 14(2), Summer, 1996,
published by: The Medical RRTC in Secondary Complications in Spinal Cord
Injury, housed at the UAB-Dept of Physical Medicine and Rehab, 1717 6th Ave.
S, Birmingham, AL 35233-7330.
The Baclofen Pump: Functional and Neuropsychological Impact on Spasticity
The development of severe upper motor neuron spasticity is a common secondary
medical complication for persons with spinal cord injury (SCI). The spasticity
is often severe enough to affect one’s ability to perform routine activities
of daily living. This can cause individuals to remain homebound, in acute care
hospitals, or in nursing care facilities. Some persons require expensive and
often irreversible surgical procedures to reduce their spasticity.
The drug, oral baclofen (Lioresal), has proven to be a relatively effective
agent for treating upper motor neuron spasticity due to spinal pathology (such
as multiple sclerosis, tumors, and spinal cord injury). Unfortunately, the
amount of baclofen a person can take orally is limited because of toxicity and
side effects such as drowsiness and lethargy. Also when taken orally, only a
small amount can penetrate to the source of the spasticity within the nervous
system. As a result, 25-35% of people with SCI who take this drug orally do
not get enough relief.

Recent research is focusing on a new way to administer the baclofen. It is
called intrathecal delivery. This means that a pump with a drug reservoir is
surgically implanted below the skin in the person’s abdomen. The pump sends
the drug directly into the cerebrospinal fluid surrounding the spinal cord.
This delivers the baclofen to the spinal cord at a much higher dosage than the
oral dosage.

Purpose
The objectives of this study are to determine the degree that intrathecal
baclofen
reduces spasticity;
improves the ability of individuals to function independently in activities of
daily living, mobility transfers, and bowel and bladder care;
changes the level of cognitive awareness;
effects the long term cost for medical/attendant care;
and produces any medical complications.
Methodology
This study collects baseline data on potential participants, followed by an
experimental dosage of baclofen to determine the response to the medication.
Additional information is collected on individuals who respond satisfactorily
to the medication. Data collected as a part of this study includes
demographics as well as measures of injury and spasticity severity, muscle
strength, functional independence, cognition and economics. The study collects
follow-up data at months 1, 3, 6, 9, and 1 year after the individual has the
pump implanted, and annually thereafter.
The method for delivering the baclofen using the pump has received approval by
the Food and Drug Administration (FDA). This RRTC research project is studying
this new treatment method against standard care.

Progress
Between December 1993 and June 1996, we have implanted 10 Baclofen pumps after
screening 17 patients. Of the ten patients, nine continue to be followed up
for data and one moved to the Oklahoma area.
I am seeing benefits that are both rewarding and practical. With this
treatment the side effects are low. It does not reduce motor function, and it
is not an irreversible procedure. This study will provide us with valuable
data because it also looks at cognitive issues and long term issues, such as
costs.

Participants continue to be accepted in this project.
For additional information contact Jay Meythaler, JD, MD or Sharon Guin-
Renfro, RN, MSN, CRNP at (205) 934-2088.