Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury
|Traumatic Brain Injury||Drug: nerve growth factor Drug: nomral saline||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Pilot Study of Intranasal Nerve Growth Factor for Traumatic Brain Injury(TBI)|
- improved neurological functions [ Time Frame: at months 6 post-treatment ]Neurological functions will be assessed by GOS(Glasgow Outcome Scale), mRS(modified Rankin Scale),BI(Barthel index).
- HAMA,HAMD [ Time Frame: at months 6 post-treatment ]HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale).
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: nerve growth factor
Patients who underwent TBI will be chosen to receive NGF randomly.
Drug: nerve growth factor
The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
Other Name: GM1
Placebo Comparator: Control
Patients who underwent TBI will be chosen to receive nomral saline randomly.
Drug: nomral saline
The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212679
|Department of Neurology, Jinling Hospital, Nanjing University School of Medicine|
|Nanjing, Jiangsu, China, 210002|
|Study Chair:||Xinfeng Liu, MD||Department of Neurology, Jinling Hospital, Nanjing University School of Medicine|