Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Intranasal Nerve Growth Factor for Traumatic Brain Injury(TBI)

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: nerve growth factor
* Drug: nomral saline


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nerve growth factor<br>Patients who underwent TBI will be chosen to receive NGF randomly. | Drug: nerve growth factor<br>* The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.<br>|
| Placebo Comparator: Control<br>Patients who underwent TBI will be chosen to receive nomral saline randomly. | Drug: nomral saline<br>* The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved neurological functions | Neurological functions will be assessed by GOS(Glasgow Outcome Scale), mRS(modified Rankin Scale),BI(Barthel index). | at months 6 post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMA,HAMD | HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale). | at months 6 post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nerve growth factor, traumatic brain injury, intranasal, prognosis, neurological function