Pulmonary function and sleep related disorders during cervical admission of intrathecal baclofen in spinal cord injury; a study protocol

Abstract Study design: multiphase single arm intervention study Objectives: The primary goal is to establish the safety of cervical infusion of intrathecal baclofen (ITB) on pulmonary and respiratory functions and sleep related disorders in persons with spinal cord injury (SCI). The secondary goal is to explore the effect of cervical ITB on reduction of spasticity and improvement at the level of functions and activities. Settings: General hospital and rehabilitation centre, The Netherlands Methods: The first phase involves a safety study in persons with SCI with functionally hindering spasticity of the upper extremity. In this phase an extracorporeal pump will be used to investigate whether cervical ITB leads to reduction of spasticity without an adverse effect on respiratory function and sleep related disorders. In case of a safe (no adverse effects) and positive (reduction of spasticity) result of the test, a baclofen pump will be implanted in the second phase of the study. The dosage of ITB will be slowly increased and oral spasmolytics phased out. At 3, 6, and 12 months after discharge, a pulse-oximetry will be performed and pulmonary function, respiratory function, level of spasticity and the level of function and activities will be assessed. Conclusion: Little is known, at present, about safety and effectiveness of cervical ITB for the treatment of upper extremity spasticity. We aim to establish the safety and efficacy of this procedure. This paper describes the protocol of this safety study.