Pulmonary function and sleep related disorders during cervical admission of intrathecal baclofen in spinal cord injury; a safety study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- The primary endpoint of the study is treatment safety, which is defined as PcCO2 between 4,7 kPa and 6,5 kPa and an AHI < 15 without complaints of SAS in patients without SAS and an AHI < 5 in patients with treated SAS. If patients use a CPAP device, it may be adjusted to stay within the safe margin. This adjustment will be registered. The spirometry is not used for safety reasons but to determine the effect of ITB on pulmonary function
研究概览
简要总结
The primary goal of the study is to demonstrate that cervical admission of intrathecal baclofen is a safe treatment without deterioration of pulmonary and respiratory function and possible increased risk or increased severity of sleep apneu syndrom
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The primary endpoint of the study is treatment safety, which is defined as PcCO2 between 4,7 kPa and 6,5 kPa and an AHI < 15 without complaints of SAS in patients without SAS and an AHI < 5 in patients with treated SAS. If patients use a CPAP device, it may be adjusted to stay within the safe margin. This adjustment will be registered. The spirometry is not used for safety reasons but to determine the effect of ITB on pulmonary function
The primary endpoint of the study is treatment safety, which is defined as PcCO2 between 4,7 kPa and 6,5 kPa and an AHI < 15 without complaints of SAS in patients without SAS and an AHI < 5 in patients with treated SAS. If patients use a CPAP device, it may be adjusted to stay within the safe margin. This adjustment will be registered. The spirometry is not used for safety reasons but to determine the effect of ITB on pulmonary function
次要结局
- Secondary endpoints are the amount of spasticity, patients satisfaction and patients level of function and activities.
研究者
Ellen Maas
Scientific
Roessingh Centrum Voor Revalidatie