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Abstract The aim of this study was to determine the efficacy and safety of intrathecal baclofen (ITB) delivered by a programmable pump for the chronic treatment of severe spasticity due to traumatic brain injury (TBI). Eight patients with severe spasticity following TBI, refractory to oral baclofen or who experienced intolerable side effects, were screened. The first five patients were enrolled in a research protocol that was approved by the Institutional Review Board for Human Research at Boston University Medical Center. The other three patients were evaluated after the FDA approved the therapy for spasticity of cerebral origin. Results showed that the mean Ashworth score for rigidity in the legs decreased from 4.4 preoperatively to 1.3 (p < 0.05) on ITB. In the arms, the Ashworth score decreased from 2.7 to 1.5 (p < 0.05). Reduction of spasticity resulted in improved levels of physical activity and locomotion and ease of care. Complications consisted of muscular hypotonia, areflexic bladder and urinary retention, erythema, and breakdown of the skin over the pump. Our results suggest that long-term intrathecal baclofen by an implanted programmable pump is a safe and effective method of treating severe intractable spasticity arising from traumatic brain injury.

Abstract We began this study to determine the efficacy and safety of intrathecal baclofen (ITB) delivered by a programmable pump for the treatment of severe spasticity of spinal cord origin. One hundred fifty two patients with severe spasticity of spinal origin, refractory to oral baclofen, or who experienced intolerable side-effects were given a test dose of ITB. Only those who had a satisfactory response were considered to be appropriate for pump implantation. All but one of the 152 patients had a satisfactory response, and the pump was implanted in 131 patients. Pre- and postoperative spasticity scores were compared and analyzed. The mean Ashworth score for rigidity decreased from 4.2 preoperatively to 1.3 (p < 0.0005) on ITB. The spasm score decreased from a mean of 3.4 to 0.6 (p < 0.0005). Reduction of spasticity resulted in improved levels of physical activity, decreased pain, and augmentation of sleep. Drug-related complications included constipation, muscular hypotonia, urinary retention, erectile dysfunction, nausea, dizziness, drowsiness, hypotension and bradycardia as well as tolerance to baclofen. Some patients experienced post-spinal puncture headaches. Catheter-related problems included occlusions, breaks, punctures, and dislodgments. Superficial pump pocket infection, pocket erosion, cerebrospinal fluid (CSF) leak, post-spinal puncture headache, and meningitis were some of the procedure-related complications. Two pumps flipped and another pump valve was stuck. We conclude that long-term intrathecal baclofen by an implanted programmable pump is a safe and effective method of treating severe intractable spinal spasticity.