Pulmonary function and sleep related disorders during cervical admission of intrathecal baclofen in spinal cord injury;a safety study - NL 68837.091.21

Roessingh Centrum Voor Revalidatie0 个研究点目标入组 11 人开始时间: 2024年4月12日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

•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

发起方

Roessingh Centrum Voor Revalidatie