Objective: To evaluate the efficacy and the safety of repeated botulinum toxin type A (BT-A) injections in patients with severe acquired brain injury (ABI) and to gain a better knowledge of possible clinical or demographic characteristics associated with a better rehabilitation outcome.
Design: Prospective study with a 1-year follow-up period.
Subjects: Twenty-one patients with spasticity due to severe ABI and no further improving with rehabilitation treatment and oral anti-spastic drugs.
Intervention: Repeated BT-A injections associated to a rehabilitation programme.
Main measures: Barthel Index (BI), Modified Ashworth Score (MAS) and VAS score for pain subjective perception were recorded.
Results: At the end of the follow-up study, MAS, BI and VAS significantly improved. Despite the number of BT-A injections, a shorter interval between severe ABI onset and first BT-A treatment correlated to a better BI improvement. None of the patients experienced adverse events attributable to BT-A.
Conclusion: BT-A was effective and safe in the treatment of spasticity in severe ABI patients, with a better functional outcome in those subjects treated earlier after spasticity onset. The lack of correlation between clinical outcome and number of injections suggests, in addition to a direct inhibition at the neuromuscular junction, a more distant BT-A long-term effect.