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

NCT03606915 | Completed DMC

• 1 other identifier: B-ER-104-070
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

pain evaluation BEHAVIORAL

collect CSF during spinal anesthesia

acute pain; chronic pain; no pain

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergo spinal anesthesia

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yen-Chin Liu, MD PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 31, 2018
• Study Start: July 10, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)