Pulmonary function and sleep related disorders during admission baclofen at the level of cervical spine in spinal cord injury; a safety study
- Conditions
- Spasticity in patients with spinal cord injuryTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-004994-30-NL
- Lead Sponsor
- Roessingh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 11
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Pregnancy
•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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method