Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Jinling Hospital, China
Sponsor:
Information provided by (Responsible Party):
Xinfeng Liu, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01212679
First received: September 30, 2010
Last updated: November 4, 2013
Last verified: November 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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)

Resource links provided by NLM:


Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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: December 2015
Estimated Primary Completion Date: December 2014 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212679

Contacts
Contact: Xinfeng Liu, MD 86-25-84801861 xfliu2@yahoo.com.cn

Locations
China, Jiangsu
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Xinfeng Liu, MD    86-25-84801861    xfliu2@yahoo.com.cn   
Principal Investigator: Xinfeng Liu, MD         
Sponsors and Collaborators
Jinling Hospital, China
Investigators
Study Chair: Xinfeng Liu, MD Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
  More Information

No publications provided

Responsible Party: Xinfeng Liu, Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01212679     History of Changes
Other Study ID Numbers: NGF-TBI
Study First Received: September 30, 2010
Last Updated: November 4, 2013
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
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014