Objective: Evaluation of the effects of intrathecal baclofen therapy (ITB) delivered by a pump implanted at a very early stage in acquired brain injury (ABI).
Study design: This investigation was a longitudinal prospective observational study, including a series of 13 ABI implanted within 6 months of the acute events.
Main outcome measure: The Modified Ashworth Scale (MAS) and Spasms Frequency Score (SFS) have been used as a primary outcome measure. The Disability Rating Scale (DRS) and Level of Cognitive Functioning (LCF) scores have been computed in order to verify possible interferences of baclofen therapy at an early stage on a global outcome. An intrathecal bolus test was not performed. Drug tolerability was tested by oral administration of baclofen 100 mg.
Results: Reduction of spasticity and spasms frequency were measured 3 months after patients received the implant and at the 1-year follow-up. There was no difference found for global outcome measure between the group of patients who received the implant earlier (within 3 months) compared to the group who received it later (between 3-6 months).
Conclusion: ITB therapy in ABI should be considered as early as possible. The implants are safe and effective in reducing spasticity. An intrathecal bolus test was not compulsory in ABI.