Baclofen Pump: Functional and Neuropsychological Impact on Spasticity

This article is from the Pushin' On Newsletter, Vol 14(2), Summer, 1996, published by: 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.