Traumatic bain injury(TBI) remains a hidden epidemic involving individuals affected predominantly at a young age who in the most severe cases remain with permanent physical,psychological and cognitive deficits.This study will investigate the therapeutic effects of intranasal Nerve Growth Factor(NGF) in TBI.
Early NGF concentration in the cerebral spinal fluid(CSF)correlates significantly with the severity of head injury, and NGF upregulation correlates with better neurologic outcomes and could be useful to obtain clinical and prognostic information in patients with serve TBI. However, the clinical use of NGF is difficulty associated with delivering them to the CNS because of the existing of blood-brain barrier(BBB). Intranasal delivery drug is a noninvasive and convenient novel method bypassing BBB, which results in targeting therapeutics to the CNS rapidly. The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post TBI, continuing for 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China
improved neurological functions
Neurological functions will be assessed by GOS(Glasgow Outcome Scale), mRS(modified Rankin Scale),BI(Barthel index).
Time frame: at months 6 post-treatment
HAMA,HAMD
HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale).
Time frame: at months 6 post-treatment
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