## Protocol Section
### Identification Module
**NCT ID:** 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)

#### Organization Study ID Info
**ID:** NGF-TBI
#### Organization
**Class:** OTHER
**Full Name:** Jinling Hospital, China
### Status Module
#### Completion Date
**Date:** 2017-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-11-01

**Type:** ACTUAL

**Last Update Submit Date:** 2017-10-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-10

**Type:** ACTUAL

#### Start Date
**Date:** 2010-12

**Status Verified Date:** 2016-11

#### Study First Post Date
**Date:** 2010-10-01
**Type:** ESTIMATED
**Study First Submit Date:** 2010-09-30
**Study First Submit QC Date:** 2010-09-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Jinling Hospital, China

#### Responsible Party

**Investigator Affiliation:** Jinling Hospital, China

**Investigator Full Name:** Xinfeng Liu

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Traumatic Brain Injury

**Keywords:**

- nerve growth factor

- traumatic brain injury

- intranasal

- prognosis

- neurological function

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 106

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: nerve growth factor

**Label:** nerve growth factor

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: nomral saline

**Label:** Control

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- nerve growth factor

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

**Name:** nerve growth factor

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control

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

**Name:** nomral saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** improved neurological functions

**Time Frame:** at months 6 post-treatment

#### Secondary Outcomes

**Description:** HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale).

**Measure:** HAMA,HAMD

**Time Frame:** at months 6 post-treatment

### Eligibility Module

**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.

-

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nanjing

**Country:** China

**Facility:** Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

**State:** Jiangsu

**Zip:** 210002

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

**Name:** Xinfeng Liu, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5207

- Name: Brain Injuries

- Relevance: HIGH

- As Found: Brain Injury

- ID: M628

- Name: Brain Injuries, Traumatic

- Relevance: HIGH

- As Found: Traumatic Brain Injury

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001930

- Term: Brain Injuries

- ID: D000070642

- Term: Brain Injuries, Traumatic

- ID: D000014947

- Term: Wounds and Injuries

### Intervention Browse Module - Ancestors

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11900

- Name: Mitogens

- Relevance: HIGH

- As Found: Mask

### Intervention Browse Module - Meshes

- ID: D000008934

- Term: Mitogens

### Misc Info Module

- Version Holder: 2024-05-24
