Pulmonary function and sleep related disorders during cervical admission of intrathecal baclofen in spinal cord injury; a safety study
Phase 4
Recruiting
- Conditions
- spinal cord injury and myelopathie10041543
- Registration Number
- NL-OMON55571
- Lead Sponsor
- Revalidatiecentrum Het Roessingh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 11
Inclusion Criteria
Cervical spinal cord injury
Spasticity of upper extremities
Exclusion Criteria
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Objective:<br /><br>The primary goal of the study is to demonstrate that cervical admission of ITB<br /><br>is a safe treatment without deterioration of pulmonary and respiratory function<br /><br>and possible increased risk or increased severity of SAS.<br /><br><br /><br>pulmonary function is mapped by means of spirometry. The quality of the<br /><br>respiration is determined by capillary blood gas. Sleep-related breathing<br /><br>disorders are measured by pulse-oximetry and polysomnography. </p><br>
- Secondary Outcome Measures
Name Time Method