Investigating the Role of Brain-derived Neurotrophic Fact... | NCT03606915

Studies
Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease

NCT03606915

Sponsor

National Cheng-Kung University Hospital

Status

Completed

Last Update Posted

Feb 26, 2020Actual

Enrollment

131Actual

Phase

Not provided

Conditions

Pain

Interventions

pain evaluation

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2015Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Jun 15, 2018

First Submission Date that Met QC Criteria

Jul 28, 2018

First Posted Date

Jul 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2020

Last Update Posted Date

Feb 26, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yen Chin Liu, Associate Professor, National Cheng-Kung University HospitalPrincipal Investigator

Lead Sponsor

National Cheng-Kung University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain markers and as a new therapeutic target for pain control.

Detailed Description

The research protocol was approved by the Institutional Review Board (IRB) for the Protection of Human Subjects at National Cheng Kung University Hospital (NCKUH/B-ER-104-070). The study procedures were performed according to the rules of IRB and fully explained to the participants. Blood and CSF samples were collected and compared the difference in no pain group, acute pain group, and chronic pain group.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

131Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
no pain	pain evaluation for patients performed surgery without painful condition (bleeding or others)	Behavioral: pain evaluation
acute pain	pain evaluation for patients performed surgery with painful condition within several days	Behavioral: pain evaluation
chronic pain	pain evaluation for patients performed surgery with the painful condition for over months	Behavioral: pain evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pain evaluation	Behavioral	collect CSF during spinal anesthesia	acute pain chronic pain no pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cytokine measurement in cerebrospinal fluid	cytokine measurement ( via ELISA) in cerebrospinal fluid	through study completion, an average of 1 year
cytokine measurement in blood	cytokine measurement (via ELISA) in blood	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

. Patients undergo spinal anesthesia
. Over 20 years of age
- Patients who are competent to understand the study and provide written informed consent.

Exclusion Criteria:

Patients have the contraindication for spinal anesthesia (refuse spinal anesthesia, coagulopathy, severe aortic stenosis)
Refuse participated in this study or pre-existent neurological disease.
Patients with advanced tumor staging (stage 3 or 4).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergo spinal anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yen-Chin Liu, MD PhD	National Cheng Kung University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cheng Kung University		Tainan		701	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

patient privacy and no patient consent

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Whole blood (10 ml) was collected before surgery using venipuncture: the blood was drawn into a test tube that contained the anticoagulant ethylenediamine tetraacetic acid (EDTA). Blood and CSF samples were ice bathed and then transported to laboratory for biological molecule analysis. White blood cells and platelets were also counted before operation as a routinely pre-operative check