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

Phase 1

Recruiting

Conditions: Spinal cord Injury
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: CTIS2023-508143-51-01

Lead Sponsor: Roessingh Centrum Voor Revalidatie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: Secondary goal of the study is to explore the effect of cervical admission of ITB on reduction of spasticity (both functional en satisfaction) and improvement at the level of patients functions and activities.;Primary end point(s): 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

Secondary Outcome Measures