| 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. |
