Nov 01, 1995
A Research Foundation Fact Sheet described the status of information about the use of a drug to reduce muscle spasticity — baclofen — and its administration by a pump implanted under the skin. Baclofen decreases the excitability of nerve cells in the spinal cord and is being used to diminish spasticity in the lower limbs in persons with spinal cord injury and disease of the spinal cord. The pump is used as a method of administering controlled amounts of the drug by a tube from pump to the spinal fluid in the space which surrounds the spinal cord. The usefulness of baclofen for the treatment of muscle spasticity associated with cerebral palsy has not been established and is under study. Also, the usefulness and safety of the pump and tube for delivering baclofen into the spinal fluid is under study. Thus, the usefulness and role of baclofen delivered by pump into the spinal fluid is undergoing clinical evaluation.
The Research Foundation has been informed by Medtronic Neurological (manufacturer of the pump) that the U.S. Food and Drug Administration (FDA) has approved a treatment protocol (a “treatment IND”) to study the use of baclofen (Lioresal7) being delivered to the spinal fluid in the treatment of spasticity of cerebral origin; this includes severe spasticity related to cerebral palsy and to head injury.
The treatment protocol approved by the FDA allows this therapy to be used at this time under investigative conditions. Persons with cerebral palsy wishing to participate in one of the clinical trials must receive treatment at a medical center that is enrolled in the Medtronic clinical study. Several medical centers are participating in the study evaluating this therapy.
In the consideration of this therapy for cerebral palsy, there are several issues that need to be addressed:
“Is the drug administered in this way effective in the treatment of spasticity associated with cerebral palsy?
“What are the side-effects of the use of the drug administered in this way?
“What are the benefits, complications and dangers of the use of the implanted pump and the delivery system to the spinal fluid?
“What is the role of other therapies usually given in conjunction with baclofen (e.g.: physiotherapy)?
“If spasticity is reduced, what are the effects on activities of daily living (e.g.: walking; positioning; etc.)?
“Given other forms of treatment for spasticity, is the procedure efficient and cost-effective in the short-term? For the long term?
If persons with cerebral palsy are interested in learning about Medtronic Neurological sponsored studies, they can obtain more information by contacting:
800 53rd Avenue, NE
P. O. Box 1250
Minneapolis, MN 55440-9087
The Research Foundation is providing this Update in order to keep you informed about approaches being evaluated for the treatment of disabilities associated with cerebral palsy.