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

Ki vehet részt

• In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Cervical SCI neurological level C1-Th1, • Functionally hindering generalized spasticity of the upper extremities with insufficient effect or too many side effects of oral spasmolytics and/or local treatments • American Spinal Injury Association (ASIA) Impairment Scale: A,B,C,D • > 1 year after onset of SCI • Over 18 years old • No progressive disease • Stabile medical situation for undergoing the ITB-trial and a final implantation of a baclofen pump after positive test • No muscle or nerve blocks < 6 months for start of study

Ki nem vehet részt

• A potential subject who meets any of the following criteria will be excluded from participation in this study: • Pregnancy • Women of child bearing potential • Nursing women • Allergy baclofen • Contra indication ITB (increased bleeding tendency, increased intracranial pressure, severe pressure ulcer) • Oral anticoagulants • Severe depression • excessive alcohol use • Patients depending on ventilation • Not adequately treated SAS • PcCO2 > 6,5 KPa