Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Traumatic Brain Injury |
Drug: nerve growth factor |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale).
| Estimated Enrollment: | 118 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: nerve growth factor
Patients who underwent TBI will be chosen to receive NGF randomly. Experimental:nomral saline group Patients who underwent TBI will be chosen to receive nomral saline randomly.
|
Drug: nerve growth factor
The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
Other Name: GM1
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
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Contacts and Locations| Contact: Xinfeng Liu, MD | 86-25-84801861 | xfliu2@yahoo.com.cn |
| China, Jiangsu | |
| Department of Neurology, Jinling Hospital, Nanjing University School of Medicine | Not yet recruiting |
| Nanjing, Jiangsu, China, 210002 | |
| Contact: Xinfeng Liu, MD 86-25-84801861 xfliu2@yahoo.com.cn | |
| Principal Investigator: Xinfeng Liu, MD | |
| Study Chair: | Xinfeng Liu, MD | Department of Neurology, Jinling Hospital, Nanjing University School of Medicine |
More Information
No publications provided
| Responsible Party: | Jinling Hospital, China |
| ClinicalTrials.gov Identifier: | NCT01212679 History of Changes |
| Other Study ID Numbers: | NGF-TBI |
| Study First Received: | September 30, 2010 |
| Last Updated: | September 30, 2010 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Jinling Hospital, China:
|
nerve growth factor traumatic brain injury intranasal prognosis neurological function |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |
Wounds and Injuries Mitogens Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013