Brain Injury Clinical Trial
Official title:
A Phase 1/2,Open-Label Study to Evaluate the Safety and Efficacy of the International Brain Research Foundation (IBRF) Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Patients With Severe Disorders of Consciousness
This is a study to evaluate the safety and efficacy of the IBRF ACP/MCP intervention protocol in patients with severe disorders of consciousness (SDOC).
Currently, there are no empirically validated, evidence-based pharmacological interventions
for the treatment of Severe Disorders of Consciousness (SDOC). In addition, it is unclear
why poly-pharmacological interventions, while more common in the treatment of other
disorders (e.g., cancer, chronic pain), have not been embraced for the treatment SDOC; some
of the lone agents used in treatment of SDOC patients are not "indicated" for combined
treatment.
In addition, the treatment of SDOC traditionally employs the use of single or small
combinations of pharmacological agents, with no single pharmacological agent being
identified as efficacious or effective. As such, a poly-pharmacological intervention may,
inherently, involve pharmacological interactions that were not anticipated by the drug
manufacturers or prescribing physicians.
The purpose of this study is to document the safety of the IBRF ACP/MCP and to establish its
efficacy for those SDOC patients successfully completing treatment. The IBRF ACP/MCP employs
a poly-pharmacological approach aimed at studying arousal states and outcomes in SDOC
patients beyond those rates documented in literature.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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