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Pulmonary function and sleep related disorders during cervical admission of intrathecal baclofen in spinal cord injury; a safety study
EU CTIS ID: 2023-508143-51-01
What this study is testing
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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.