Trial reportBMC neurology2026
Evaluation of long-term quality of life in traumatic brain injury patients early treated with biperiden - a randomized controlled trial.
Trial report in BMC neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01048138 (Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study
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Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTraumatic brain injury (TBI) is a leading cause of disability, with post-traumatic epilepsy (PTE) being a major complication. Biperiden has shown experimental potential in preventing epileptogenesis, however its impact on outcomes, such as quality of life (QoL), remains unknown. This study evaluated long-term QoL in TBI survivors treated with biperiden and identified clinical and socioeconomic predictors of their QoL.
methodsWe analyzed QoL data from a randomized, double-blind, placebo-controlled trial involving 48 adults with moderate to severe TBI, assessed on average 32 months post-injury. QoL was measured using the EQ-5D-3 L questionnaire. A cross-sectional analysis identified predictors of QoL using Generalized Linear Models (GLMs), and a longitudinal analysis of a 14-participant subgroup assessed changes over time using a paired t-test.
resultsEarly treatment with biperiden did not significantly alter QoL compared to placebo. However, the study identified significant negative predictors for QoL: the presence of PTE (β = -0.23, p = 0.02), temporal lobe lesion (β = -0.22, p = 0.006), and being a beneficiary (p = 0.002). QoL scores significantly improved between 11.6 months (0.457) and 27.1 months (0.678) post-TBI (p = 0.004). Descriptively, while mobility and self-care were well-preserved, the anxiety/depression dimension was the most affected dimension, with 22.5% of participants reporting extreme problems.
conclusionsBiperiden did not impact QoL in TBI survivors. However, improvements were observed in the approximately 2 years following injury. Predictors like PTE, temporal lesions and receiving benefits as income were associated with lower Qol score. These preliminary findings guide future interventions for TBI patients and are particularly important as they fill a data gap for the Brazilian population.
trial registrationThe trial was registered at ClinicalTrials.gov, a database managed by the U.S. National Library of Medicine (NLM) and National Institutes of Health (NIH), under the identifier NCT01048138 on January 13, 2010.
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