JMIR Publications

ABSTRACT

Background:

The effect and safety of intrathecal baclofen (ITB) on general spasticity of the lower extremities has been well described in numerous studies, whereas the safety and effect on spasticity of the upper extremities during cervical administration seems to be less certain.

Objective:

The primary goal of this study is to establish the safety of cervical administration of ITB on pulmonary function and sleep-related disorders in adults with a cervical spinal cord injury (SCI) with functional hindering spasticity. The secondary goal is to explore the effect of cervical ITB on reduction of spasticity, on participant satisfaction and on improvement at the level of functions, activities and participation.

Methods:

The study is a multiphase single arm intervention study. Before start of the study participants are screened for presence of sleep-related disorders and pulmonary function is checked by using spirometry and capillary bloodgas sample. Participants are allowed to start the first phase of the study if there are no signs of sleep-related disorders or these are adequately treated. The PcCO2 has to be between 4,5 and 6,5 Kpa. In the first phase of the study, an extracorporeal pump will be used to investigate whether cervical administration of ITB leads to reduction of spasticity without an adverse effect on pulmonary function and sleep-related disorders. In case of a safe (no adverse effects) and positive (reduction of spasticity) result of the trial, a baclofen pump will be implanted in the second phase of the study. After implantation the dosage of ITB will be slowly increased and eventually used oral spasmolytics are phased out. Increase in dosage will be done under monitoring of pulmonary function and sleep-related disorders. In the second phase of the study a pulse-oximetry will be performed and pulmonary function, spasticity, satisfaction and level of function, activities and participation will be assessed at 3, 6 and 12 months after definitive implantation of the baclofen pump.

Results:

The first participant was included on May 23, 2023. Data collection and analysis are expected to be completed in 2027.

Conclusions:

Currently, little is known about the safety and effectiveness of cervical administration of ITB for the treatment of upper extremity spasticity. We aim to establish the safety and explore efficacy of this procedure. This paper describes the protocol of this study. Clinical Trial: The trial is registered in the EudraCTdatabase (2021-004994-30) and is transitioned and authorized by CITS at 6-5-2024 (2023-508143-51-01).