Traumatic Brain Injury
Conditions
Keywords
nerve growth factor, traumatic brain injury, intranasal, prognosis, neurological function
Brief summary
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.
Detailed description
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.
Interventions
The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
DRUGnomral saline
The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Moderate to severe blunt traumatic brain injury defined as Glasgow Coma Scale(GCS) between 7 and 13. Age 18\ 65 years. Admission to Jinling Hospital between 24 to 72 hours. Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
Exclusion criteria
Skull fracture, Cerebrospinal fluid rhinorrhea. Severe concurrent illness with life expectancy\<6 months or other serious illness which have a major impact on the outcome. Treatment with other investigational agents in the past 4 weeks. Allergy to NGF. Primary ciliary dyskinesia, Asthma, Cystic fibrosis, Viral and bacterial infections, Diabetes mellitus. Inability to provide informed consent. Pregnancy or breast-breeding. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improved neurological functions | at months 6 post-treatment | Neurological functions will be assessed by GOS(Glasgow Outcome Scale), mRS(modified Rankin Scale),BI(Barthel index). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HAMA,HAMD | at months 6 post-treatment | HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale). |
Countries
China
Outcome results
None listed