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Intrathecal Baclofen for Management of Spastic Cerebral Palsy: Multicenter Trial

HCA/Wesley Medical Center, Neurology Center of Wichita Wichita, KS

Derek Bruce, MD

Medical City Dallas Hospital Dallas, TX

Bruce B. Storrs, MD

Medical University of South Carolina Charleston, SC

Rick Abbott, MD

New York Medical Center, Division of Pediatric Neurosurgery New York, NY

Linda Krach, MD

Gillette Children's Hospital St Paul, MN

John Ward, MD

Medical College of Virginia Richmond, VA

Karen Bloom, MD

Frazier Rehabilitation Center Louisville, KY

William H. Brooks, MD

Good Samaritan Hospital, Neurological Associates Lexington, KY

Dennis L. Johnson, MD

Hershey Medical Center, Division of Neurosurgery Hershey, PA

Joseph R. Madsen, MD

Children's Hospital of Boston dsen), Boston, MA

John F. McLaughlin, MD

Children's Hospital and Medical Center Seattle, WA

Joseph Nadell, MD

Children's Hospital New Orleans, LA

Intrathecal baclofen infusion has demonstrated effectiveness in decreasing spasticity of spinal origin. Oral antispasticity medication is minimally effective or not well tolerated in cerebral palsy. This study assessed the effectiveness of intrathecal baclofen in reducing spasticity in cerebral palsy. Candidates were screened by randomized, double-blind, intrathecal injections of baclofen and placebo. Responders were defined as those who experienced an average reduction of 1.0 in the lower extremities on the Ashworth Scale for spasticity. Responders received intrathecal baclofen via the SynchroMed System and were followed for up to 43 months. Fifty-one patients completed screening and 44 entered open-label trials. Lower-extremity spasticity decreased from an average baseline score of 3.64 to 1.90 at 39 months. A decrease in upper-extremity spasticity was evidenced over the same study period. Forty-two patients reported adverse events. Most common reports were hypotonia, seizures (no new onset), somnolence, and nausea or vomiting. Fifty-nine percent of the patients experienced procedural or system-related events. Spasticity in patients with cerebral palsy can be treated effectively by continuous intrathecal baclofen. Adverse events, although common, were manageable. (J Child Neurol 2000;15:71-77).

Journal of Child Neurology, Vol. 15, No. 2, 71-77 (2000)
DOI: 10.1177/088307380001500201


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