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Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

nerve growth factor

nomral saline

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring nerve growth factor, traumatic brain injury, intranasal, prognosis, neurological function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

nerve growth factor

Control

Arm Description

Patients who underwent TBI will be chosen to receive NGF randomly.

Patients who underwent TBI will be chosen to receive nomral saline randomly.

Outcomes

Primary Outcome Measures

improved neurological functions

Neurological functions will be assessed by GOS(Glasgow Outcome Scale), mRS(modified Rankin Scale),BI(Barthel index).

Secondary Outcome Measures

HAMA,HAMD

HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale).

Full Information

NCT ID

NCT01212679

First Posted

September 30, 2010

Last Updated

October 30, 2017

Sponsor

Jinling Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT01212679

Brief Title

Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinling Hospital, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

nerve growth factor, traumatic brain injury, intranasal, prognosis, neurological function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nerve growth factor

Arm Type

Experimental

Arm Description

Patients who underwent TBI will be chosen to receive NGF randomly.

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Patients who underwent TBI will be chosen to receive nomral saline randomly.

Intervention Type

Drug

Intervention Name(s)

nerve growth factor

Intervention Description

The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

nomral saline

Intervention Description

The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.

Primary Outcome Measure Information:

Title

improved neurological functions

Description

Neurological functions will be assessed by GOS(Glasgow Outcome Scale), mRS(modified Rankin Scale),BI(Barthel index).

Time Frame

at months 6 post-treatment

Secondary Outcome Measure Information:

Title

HAMA,HAMD

Description

HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale).

Time Frame

at months 6 post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xinfeng Liu, MD

Organizational Affiliation

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury

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