Efficacy of oral modafinil on accelerating consciousness recovery in adult patients with moderate to severe acute traumatic brain injury admitted to intensive care unit: a randomized double-blind clinical trial

Traumatic Brain Injury (TBI) is a leading cause of hospitalization and disability in young and middle-aged adults. This study aims to survey the efficacy of oral modafinil, a low-side-effect central nervous system stimulant, in the enhancement of consciousness recovery in moderate to severe TBI patients in the ICUs of a referral trauma center.

All ICU patients meeting inclusion criteria between April 2021 and April 2023 were screened. Eligible patients had a motor Glasgow Coma Score(GCS) of 4 or 5 and did not receive continuous intravenous sedatives within 24 h before screening. They were randomly assigned to receive 200mg of enteral modafinil or placebo daily for 7 days. Motor GCS and total GCS scores, ICU/hospital stay duration, mechanical ventilation requirement, tracheal tube removal time, and tracheostomy needs were recorded.

Among the included 85 eligible patients, there was no significant difference between the modafinil and placebo groups in the median days between the intervention and the time of a 2-unit increase in total GCS (P = 0.25) or a 1-unit increase in motor GCS (P-value = 0.31). The group assignment also had no impact on the mean GCS (P-value = 0.533) and mean motor GCS (P-value = 0.167) over time. The only significant difference was in the proportion of patients with an increase in total GCS by 2 units, which was 54% for the modafinil vs. 32% for the placebo group (P-value = 0.04), and an increase in motor GCS by 1 unit, with 56% in the modafinil vs. 34% in the placebo group (P-value = 0.04).

The administration of modafinil appears to be safe and beneficial for patients with severe TBI during their stay in the ICU.